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Is it (3) identical batches of 1kg FluCide(TM) material in about (3) months? Well, let Pumpy do the math.
What does it mean that the term was used in the Detailed Description section of another company's patent, specifically US Patent #8,871,799?...All three of the above patents were granted during the last 9 months and assigned to Kineta, Inc. (Seattle, WA). Is Nanoviricide's FluCide™ the Binding Site Mimetic referred to in those patents or are they referring to some other FluCide? ~ loanranger
Kineta must include FluCide(TM) in its patent application if there is any relationship between their IP claims and any prior art that lead to their discovery or invention. ~ BigKahuna
From NanoViricides, Inc. - October 7, 2013 Press Release,
...the Company announced that in this small animal non-GLP safety/toxicology study of NV-INF-1 drug candidate, even at maximum feasible dosage, the drug was well tolerated and that no adverse events were found at study completion. The Company is awaiting a full report on the chemistry and histology data from this study. These results are consistent with our findings during efficacy studies of this drug candidate in lethally infected mouse models. The Company is currently performing scale up studies on its FluCide drug candidate in its existing facilities. Upon scale-up, we will be able to produce the quantities of materials we need for the GLP Safety/Toxicology study of the injectable FluCide drug. We intend to begin the GLP Safety/Toxicology study as soon as feasible.
We anticipate that our facility will be the only anti-viral nanomedicine cGMP production facility in the world (or the US for sure) ~ Eugene Seymour, MD, MPH, CEO of NanoViricides, Inc.
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
MersCide
Waiting for Public Health England to request the drug (sitting on the shelf) for testing. They got distracted by the Ebola outbreak
EbolaCide
Making more drug for continuation of the testing by USAMRIID
Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!
Eugene Seymour MD MPH
Chief Executive Officer NanoViricides, Inc eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
All three of the above patents were granted during the last 9 months and assigned to Kineta, Inc. (Seattle, WA). Is Nanoviricide's FluCide™ the Binding Site Mimetic referred to in those patents or are they referring to some other FluCide?
...fundamental vision of translational medicine, which is to efficiently and effectively translate basic scientific findings relevant to human disease into knowledge that benefits patients --- http://ebooks.cambridge.org/chapter.jsf?bid=CBO9780511976087&cid=CBO9780511976087A010
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
MersCide
Waiting for Public Health England to request the drug (sitting on the shelf) for testing. They got distracted by the Ebola outbreak
EbolaCide
Making more drug for continuation of the testing by USAMRIID
Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
Your "compadres", those that cackle/post ad nauseum with "missing links", were proclaiming the deletion of NNVC from Russell 2000. The posters now proclaim a sell-off will begin and now you (better late than never) say, "...isn't a high dollar value source of fund participation" as if saying, it doesn't matter...?!?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=111465123
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=113445166
In this report we present our latest predictions for the upcoming Russell Annual Reconstitution. Our analysis uses market data as of the close Friday, which is the official Russell ranking date. In addition to constituent changes, we have included our anticipated Growth/Value style and float factor changes that will be implemented at the Reconstitution.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=102940919
[The FACTS are that there is no pharma company out there that has a drug for the FLU, one that is as safe and effective as FluCide(TM). You can find government "juiced up" companies with goals for a broad spectrum drug but none with preclinical studies results like FluCide(TM):]
NanoViricides, Inc. - FluCide(TM) - About FluCide(TM) Data presented at the 3rd Annual Influenza Conference held by GTC Bio on Friday, July 11
The Company believes that its FluCide™ drug candidate will be effective against most if not all influenza viruses, including the H7N9 bird flu, H3N2 or H1N1 epidemic viruses, H5N1 bird flu, seasonal influenzas, as well as novel influenza viruses. This is because FluCide is based on the Company’s biomimetic technology, mimicking the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide® polymeric micelle. It is important to note that all influenza viruses bind to the sialic acid receptors, even if they rapidly mutate. The FluCide drug candidates have already shown strong effectiveness against H1N1 and H3N2 influenza viruses in highly lethal animal models. The injectable FluCide drug candidate has shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care, in a highly lethal influenza infection animal model. The Company believes that these animal model results should translate readily into humans.
NanoViricides has also developed an oral drug candidate against influenza. This oral version was found to be dramatically more effective than oseltamivir (TamiFlu®) in animals given a highly lethal level of influenza virus infection. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth.
Read more:
http://finance.yahoo.com/news/nanoviricides-president-dr-diwan-presented-120000451.html
http://www.prnewswire.com/news-releases/nanoviricides-provides-an-update-on-its-progress-over-the-last-quarter-300061129.html
We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.
http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Files%20Quarterly%20Report%20for%20Period%20Ending%202015-03-31.html
[Seems to me they have completed the 1kg scale-up recipe and about 1kg is all we will need for clinical trials.]
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
MersCide
Waiting for Public Health England to request the drug (sitting on the shelf) for testing. They got distracted by the Ebola outbreak
EbolaCide
Making more drug for continuation of the testing by USAMRIID
Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
What a Bad Flu Season Could Cost the U.S. Economy
This year's unusually potent flu is bad news for most employers but great for drugstores
by John Tozzi
December 10, 2014 — 11:04 AM EST
This year's flu season looks worse than usual. The Centers for Disease Control (CDC) warned last week that the dominant influenza virus right now, H3N2, typically signals a severe flu season, resulting in more deaths and hospital trips than average. Even worse: About half of the H3N2 viruses detected so far are different strains from the ones included in this year's vaccine, which means flu shots will be less effective.
The resulting misery for millions of Americans is also lousy news for the economy. Flu incurs direct costs, such as the price of medical treatment, and indirect costs, such as lost productivity when workers stay home sick. There's also the cost of lost life: Influenza kills between 3,000 and 49,000 people in the U.S. each year, generally older people, young children, or people with medical conditions such as lung or heart disease that make them vulnerable to complications. The CDC recommends that everyone (except infants less than six months old) get vaccinated, especially those considered high-risk because of other health conditions...
Tallying the total cost of flu is difficult. In a 2007 article published in the journal Vaccine, CDC researchers put the total economic burden at $87 billion annually, in 2003 dollars, counting a statistical measure that puts a dollar value on lost life. Among the costs: 3.1 million days patients spend in hospitals, 10 times as many doctors visits, and 44 million days of missed work. The estimates come with a high level of uncertainty, though: Researchers calculated the total cost in a range from $47 billion to $150 billion a year. The CDC is updating these numbers, but there's no telling when they'll be ready...
http://www.bloomberg.com/news/articles/2014-12-10/flu-what-a-bad-influenza-season-could-cost-the-us-economy
Health officials hope new flu vaccine is more effective than last one
...
Both the injected vaccine and the nasal spray vaccine will be newly formulated for the coming flu year, in the hope that it will provide better coverage than their predecessors.
The U.S. Centers for Disease Control and Prevention said on Friday the vaccine for the 2015-2016 flu season will protect against a specific strain of the Type A H3N2 virus, which was missing in the 2014-2015 vaccine.
The trivalent vaccine will protect against a type of influenza B as well as H3N2 and the H1N1 virus that caused the 2009 pandemic, CDC said in a report in its publication Mortality and Morbidity Weekly Report. The quadrivalent vaccine will cover those viruses as well as a second Type B strain, it said.
According to the report, the change in the composition of the vaccine is driven by a host of factors, including surveillance around the world of dominant flu viruses.
Health officials hope the new vaccine mix proves to be more protective than the current vaccine, which only was about 19 percent effective across all age groups and 15 percent effective in children, CDC said earlier this year.
Flu season normally lasts from October to May. Vaccine manufacturers need six months to develop a supply for the coming year, CDC said.
Determining the composition of the seasonal flu vaccine is a combination of viral detective work and informed guessing. The H3N2 flu strain last year "drifted," or mutated, and by the time epidemiologists saw what was in circulation, it was too late to change the vaccine recipe given to manufacturers.
One potential problem is whether the current avian flu epidemic, which has wiped out 45 million turkeys and chickens in the Midwest, will have an impact on production. The flu vaccine is made several ways, but primarily by injecting the virus into a fertilized chicken egg, which provides a rich environment for the development of the virus. It then is extracted for the vaccine.
Liz Power, a spokeswoman for Novartis, one of the vaccine manufacturers, said the outbreak hasn't affected its production because it also used a cell culture process that uses animal cells, not chicken eggs, in the production of the vaccine.
Another vaccine manufacturer, GlaxoSmithKline, said it uses eggs from farms in Canada and Germany dedicated to production solely for vaccines, it said in a statement. The company is monitoring the outbreak and is reinforcing biosafety standards, it said.
"This method of production has the potential to yield large quantities of vaccine quickly, which is beneficial in the event of a pandemic," Power said.
CDC called the current flu season "moderately severe," and said the flu was tough this year on senior citizens. The rate of hospitalizations for people 65 and older with the flu was the highest it has been since the agency began tracking hospitalizations by age group in 2005, it said.
Nationwide, nearly 18,000 people were hospitalized with the flu, and 141 young children died from complications from the flu, the CDC report said.
In New Jersey, Department of Health data show that hospitals reporting patients with influenza-like symptoms shot up in mid- to late December, and beganfalling about a month later.
Spokeswoman Donna Leusner said flu activity started early in the season, which begins in the fall, and kept health providers busy throughout the season. The department's data show 102 outbreaks in long-term care homes for the season.
New Jersey's contribution to the 2015-2016 flu vaccine is through its monthly surveillance reports sent to CDC, she said.
Despite the low effectiveness rate for the flu vaccine in the 2014-2015 flu season, CDC still recommends getting a vaccine. There is no guarantee it will work, but the vaccine usually provides a protective benefit around 60 percent to 65 percent...
http://www.nj.com/healthfit/index.ssf/2015/06/new_flu_vaccine_formula_readied_for_the_coming_flu.html
[...they are guessing?...guessing?]
Big Pharma
Big Pharma is the nickname given to the world's vast and influential pharmaceutical industry and its trade and lobbying group, the Pharmaceutical Research and Manufacturers of America or PhRMA. These powerful companies make billions of dollars a year by selling drugs and medical devices.
Big Pharma wields enormous influence over the prescription drug and medical device markets around the globe. In fact, in the United States, the industry contributes heavily to the annual budget of the U.S. Food and Drug Administration (FDA), which is charged with regulating drugs and devices made by those same companies.
The industry demonstrates its power, political might and social influence over the nation’s governments and agencies, its health care systems, its doctors and hospitals, as well as the psyche of the American people. With the help of staggering profits and 1,100-plus paid lobbyists, the industry has gained powerful leverage on Capitol Hill.
From 1998 to 2013, Big Pharma spent nearly $2.7 billion on lobbying expenses — more than any other industry and 42 percent more than the second highest paying industry: insurance. And since 1990, individuals, lobbyists and political action committees affiliated with the industry have doled out $150 million in campaign contributions...
http://www.drugwatch.com/manufacturer/
NanoViricides President Dr. Diwan Presented FluCide Data at the 3rd Annual Influenza Conference held by GTC Bio on Friday, July 11
...
The data indicate that both NV-INF-1 and NV-INF-2 are highly effective, broad-spectrum, anti-influenza drugs. The Company has shown that they are effective against both group I and group II influenza A viruses.
Dr. Diwan also reported that the Company is successfully scaling up production of NV-INF-1 for the GLP Safety/Toxicology study at its current facilities. In addition, he reported that construction of the Company's new facility capable of cGMP production of all of the Company's nanoviricides drug candidates for human clinical batches is now complete. Facility testing and validation are in progress.
The market size for an effective influenza drug for treating severely ill hospitalized patients has been estimated in the billions of dollars, worldwide, depending upon the therapeutic value and cost savings. Currently, there is no effective therapeutic available for this indication. The Company believes that it could supply a substantial portion of the demand for this drug from its new small scale cGMP clinical drug facility. This drug is currently in IND-enabling studies.
This broad-spectrum FluCide drug is expected to work against most, if not all, forms of influenza virus, including epidemic, pandemic (e.g. H1N1/2009), high path influenzas such as H3N2, H7N9, and "bird flu" such as H5N1.
http://www.nanoviricides.com/press%20releases/2014/NanoViricides%20President%20Dr.%20Diwan%20Presented%20FluCide%20Data%20at%20the%203rd%20Annual%20Influenza%20Conference%20held%20by%20GTC%20Bio%20on%20Friday,%20July%2011.html
[No drug/vaccine company out there has pre-clinical data like that of NanoViricides, Inc.]
[On Apr 6, 2015...]
We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.
We are happy to announce that our Biological Characterization Group has now completely moved to our Shelton, CT campus. We are implementing a phased move to Shelton so that there is minimal impact on our continuing operations. We plan on continuing to use our West Haven facility to maximize R&D efforts on our large number of drug development programs.
http://www.prnewswire.com/news-releases/nanoviricides-provides-an-update-on-its-progress-over-the-last-quarter-300061129.html
[On May 18th, 2015...]
We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.
http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Files%20Quarterly%20Report%20for%20Period%20Ending%202015-03-31.html
[Can we say we are now making material, the first 1kg of identical batches for the last phase (Phase III)of tox studies in large animals?]
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
MersCide
Waiting for Public Health England to request the drug (sitting on the shelf) for testing. They got distracted by the Ebola outbreak
EbolaCide
Making more drug for continuation of the testing by USAMRIID
Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
NanoViricides Announces Delivery of FluCide to BASi to Begin Toxicology Studies
Published on October 3, 2014 at 7:40 AM
NanoViricides, Inc. reports that it has shipped FluCide™ to BASi for the start of toxicology studies. NanoViricides has chosen BioAnalytical Systems Inc. Toxicology Services of West Lafayette, Indiana to perform our safety/toxicology studies as needed for an IND submission of the Injectable FluCide drug candidate.
In other news, NanoViricides reported that the synthesis of its anti-Ebola second generation drug candidates has started. We anticipate being able to evaluate these against Ebola virus with certain of our previous collaborators. The contracts to enable such evaluation are currently in progress. The Company’s nanomedicine technology enables development of drugs that directly attack the virus, in a manner that a virus may not be able to overcome despite mutational changes. This is very important for the current epidemic-causing Ebola virus strain, which has been shown to be mutating rapidly.
Injectable FluCide was found to be extremely safe in mice in a preliminary safety study. This study showed no evidence of any adverse events even at the maximum tolerable dose level. No significant changes in all observed parameters were found even at the maximum feasible dose of approximately 2,700 mg/kg/d repeatedly given for five consecutive days.
With this information, and in consultation with BASi, we designed the safety/toxicology protocols for certain starting studies. We estimated that the total “Tox Package” studies would need as much as 2.5kg of the drug substance. Recently we broke up the study into parts and developed a starting study protocol that would require a 200g batch. Simultaneously, we have successfully scaled up our synthesis processes in the current Wood Street facilities, to be able to produce a 200g batch. The material we produced has gone through certain tests for its quality. We then prepared the samples as per the protocol design, and we have shipped them to BASi yesterday.
Nanoviricides Reports that the FluCide Candidate was found to be Very Safe in cGLP-like Safety and Toxicology Study in Rats Performed by BASi
http://www.prnewswire.com/news-releases/nanoviricides-reports-that-the-flucide-candidate-was-found-to-be-very-safe-in-cglp-like-safety-and-toxicology-study-in-rats-performed-by-basi-300024776.html
[About three months later...]
WEST HAVEN, CONNECTICUT -- Thursday, January 22, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a nanomedicine company developing anti-viral drugs, reported a good safety profile of an optimized FluCide® drug candidate in a GLP-like toxicology study in rats. These results are extremely important since they indicate that FluCide continues to look very promising as one of the most advanced candidates in the Company's drug development pipeline.
No direct adverse clinical effects were found upon administration of the FluCide candidate intravenously at doses of up to 300mg/kg/day for 14 days (a total of 4,200mg/kg) in rats. Organs were examined for gross histological observations. Microscopic histological tissue analysis was also performed. There were no adverse histological findings in gross organ level histological examination, nor were there any adverse findings in microscopic histological analysis. Equally importantly, there were no meaningful effects observed on animal weight gain, food consumption, hematology, or clinical chemistry at the end of the 14 day dosing period.
The study was conducted at BASi (Bioanalytical Systems, Inc., NASDAQ: BASI) in Evansville, Indiana. The study was performed in a cGLP-like fashion, compliant with BASi Evansville standard operating procedures. BASi has over 40 years of experience providing contract research services and niche instrumentation to the life sciences, primarily drug research and development.
http://www.nanoviricides.com/press%20releases/2015/Nanoviricides%20Reports%20that%20the%20FluCide%20Candidate%20was%20found%20to%20be%20Very%20Safe%20in%20cGLP-like%20Safety%20and%20Toxicology%20Study%20in%20Rats%20Performed%20by%20BASi.html
[It took approximately 3 months for NanoViricides, Inc. to get the results from BASi for GLP Toxicology Study, Phases I and II. If GLP toxicological study (Phase 1, 2 and 3) take up to nine months(after commissioning the study), 3 of which are reporting on results, can we say Phase III will take 3 months and 2 months of reporting? And that is a "Puffer-like" conservative estimate.]
On Apr 6, 2015...
We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.
We are happy to announce that our Biological Characterization Group has now completely moved to our Shelton, CT campus. We are implementing a phased move to Shelton so that there is minimal impact on our continuing operations. We plan on continuing to use our West Haven facility to maximize R&D efforts on our large number of drug development programs.
http://www.prnewswire.com/news-releases/nanoviricides-provides-an-update-on-its-progress-over-the-last-quarter-300061129.html
On May 18th, 2015...
We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.
http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Files%20Quarterly%20Report%20for%20Period%20Ending%202015-03-31.html
[We have likely developed the 500g scale-up recipe for FluCide (TM), and now the 1kg scale-up recipe. Can we say we are now making material, the first 1kg of identical batches for the last phase of tox studies in large animals?]
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
MersCide
Waiting for Public Health England to request the drug (sitting on the shelf) for testing. They got distracted by the Ebola outbreak
EbolaCide
Making more drug for continuation of the testing by USAMRIID
Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
On Apr 6, 2015...
We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.
We are happy to announce that our Biological Characterization Group has now completely moved to our Shelton, CT campus. We are implementing a phased move to Shelton so that there is minimal impact on our continuing operations. We plan on continuing to use our West Haven facility to maximize R&D efforts on our large number of drug development programs.
http://www.prnewswire.com/news-releases/nanoviricides-provides-an-update-on-its-progress-over-the-last-quarter-300061129.html
On May 18th, 2015...
We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.
http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Files%20Quarterly%20Report%20for%20Period%20Ending%202015-03-31.html
[We have likely developed the 500g scale-up recipe for FluCide (TM), and now the 1kg scale-up recipe. Can we say we are now making material, the first of identical batches of 1kg for the last phase of tox studies in large animals?]
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
MersCide
Waiting for Public Health England to request the drug (sitting on the shelf) for testing. They got distracted by the Ebola outbreak
EbolaCide
Making more drug for continuation of the testing by USAMRIID
Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
The FACTS are that there is no pharma company out there that has a drug for the FLU, one that is as safe and effective as FluCide(TM). You can find government "juiced up" companies with goals for a broad spectrum drug but none with preclinical studies results like FluCide(TM):
NanoViricides, Inc. - FluCide(TM) - About FluCide(TM) Data presented at the 3rd Annual Influenza Conference held by GTC Bio on Friday, July 11
The Company believes that its FluCide™ drug candidate will be effective against most if not all influenza viruses, including the H7N9 bird flu, H3N2 or H1N1 epidemic viruses, H5N1 bird flu, seasonal influenzas, as well as novel influenza viruses. This is because FluCide is based on the Company’s biomimetic technology, mimicking the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide® polymeric micelle. It is important to note that all influenza viruses bind to the sialic acid receptors, even if they rapidly mutate. The FluCide drug candidates have already shown strong effectiveness against H1N1 and H3N2 influenza viruses in highly lethal animal models. The injectable FluCide drug candidate has shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care, in a highly lethal influenza infection animal model. The Company believes that these animal model results should translate readily into humans.
NanoViricides has also developed an oral drug candidate against influenza. This oral version was found to be dramatically more effective than oseltamivir (TamiFlu®) in animals given a highly lethal level of influenza virus infection. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth.
Read more:
http://finance.yahoo.com/news/nanoviricides-president-dr-diwan-presented-120000451.html
http://www.prnewswire.com/news-releases/nanoviricides-provides-an-update-on-its-progress-over-the-last-quarter-300061129.html
We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.
http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Files%20Quarterly%20Report%20for%20Period%20Ending%202015-03-31.html
[Seems to me they have completed the 1kg scale-up recipe:]
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals
MersCide
Waiting for Public Health England to request the drug (sitting on the shelf) for testing. They got distracted by the Ebola outbreak
EbolaCide
Making more drug for continuation of the testing by USAMRIID
Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!
Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
eugene@nanoviricides.com
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange
Flu shot only 19% effective this winter
Liz Szabo, USA TODAY 5:03 p.m. EDT June 4, 2015
Flu vaccines were only 19% effective in preventing doctor visits for influenza this season, one of the lowest rates in the past decade, the Centers for Disease Control and Prevention said Thursday.
Health officials had predicted flu shots would be less protective than usual this year. That's because the viruses used to make the flu shots weren't a good match for the dominant strains of influenza in circulation, said Brendan Flannery, an epidemiologist in the CDC's influenza division.
Scientists face a difficult challenge each year when selecting the virus strains to be included in seasonal flu shots, said Andrew Pekosz, an associate professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore. That's because flu viruses, unlike the measles or polio viruses, undergo significant genetic changes each year. So the vaccine needs to change every year, too.
Scientists from the CDC and Food and Drug Administration survey the dominant flu strains annually and make their selections in February, Flannery said. That gives manufacturers about six months to produce the vaccines, which ship out to clinics the following fall. Last year, however, flu viruses began mutating almost as soon as companies began production.
Read more: http://www.usatoday.com/story/news/2015/06/04/flu-shot-effective/28465601/
NanoViricides, Inc. - FluCide(TM) - About FluCide(TM) Data presented at the 3rd Annual Influenza Conference held by GTC Bio on Friday, July 11
The Company believes that its FluCide™ drug candidate will be effective against most if not all influenza viruses, including the H7N9 bird flu, H3N2 or H1N1 epidemic viruses, H5N1 bird flu, seasonal influenzas, as well as novel influenza viruses. This is because FluCide is based on the Company’s biomimetic technology, mimicking the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide® polymeric micelle. It is important to note that all influenza viruses bind to the sialic acid receptors, even if they rapidly mutate. The FluCide drug candidates have already shown strong effectiveness against H1N1 and H3N2 influenza viruses in highly lethal animal models. The injectable FluCide drug candidate has shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care, in a highly lethal influenza infection animal model. The Company believes that these animal model results should translate readily into humans.
NanoViricides has also developed an oral drug candidate against influenza. This oral version was found to be dramatically more effective than oseltamivir (TamiFlu®) in animals given a highly lethal level of influenza virus infection. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth.
Read more:
http://finance.yahoo.com/news/nanoviricides-president-dr-diwan-presented-120000451.html
http://www.prnewswire.com/news-releases/nanoviricides-provides-an-update-on-its-progress-over-the-last-quarter-300061129.html
...
The data indicates that both NV-INF-1 and NV-INF-2 are highly effective, broad-spectrum, anti-influenza drugs. The Company has shown that they are effective against both group I and group II influenza A viruses.
Dr. Diwan also reported that the Company is successfully scaling up production of NV-INF-1 for the GLP Safety/Toxicology study at its current facilities. In addition, he reported that construction of the Company’s new facility capable of cGMP production of all of the Company’s nanoviricides drug candidates for human clinical batches is now complete. Facility testing and validation are in progress.
http://www.prnewswire.com/news-releases/nanoviricides-inc-completes-purchase-of-cgmp-compliant-pilot-production-facility-300017051.html
...
No failures in 5000 plus animals and...
"...we don't anticipate any in humans because remember, we are agnostic to the host...we don't care if you are a man, a mouse, a whale, or a salamander. As long as you have a virus in your circulation, we destroy it!"~ Dr. Eugene Seymour, CEO of NanoViricides, Inc.
We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.
The Deadliest Virus
Did a scientist put millions of lives at risk—and was he right to do it?
By Michael Specter
...
Last December, the National Science Advisory Board for Biosecurity, a panel of science, defense, and public-health experts, was asked by the Department of Health and Human Services to evaluate Fouchier’s research. The panel recommended that the two principal scientific journals, Science and Nature, reconsider plans to publish information about the methods used to create the H5N1 virus. It was the first time that the Advisory Board, which was formed after the anthrax attacks of 2001 to provide guidance on “dual use” scientific research, which could both harm and protect the public, had issued such a request. “We are in the midst of a revolutionary period in the life sciences,” the advisers wrote. “With this has come unprecedented potential for better control of infectious diseases and significant societal benefit. However, there is also a growing risk that the same science will be deliberately misused and that the consequences could be catastrophic.” The Times published an editorial that echoed the Advisory Board’s concern, and even questioned the purpose of the experiments: “We believe in robust research and almost always oppose censorship. But in this case the risks—of doing the work and publishing the results—far outweigh the benefits.” The journal New Scientist agreed: “ONE MISTAKE AWAY FROM A WORLDWIDE FLU PANDEMIC.” Television talk shows and the Internet pulsated with anxiety.
The widespread alarm led Science and Nature to agree to postpone publication. Fouchier’s virus, which now sits in a vault within his securely guarded underground laboratory in Rotterdam, has fundamentally altered the scope of the biological sciences. Like the research that led to splitting the atom and the creation of nuclear energy, the knowledge that his experiment has provided could be used to attack the public as well as to protect it.
“Terror is not an unjustified reaction to knowing this virus exists,” Osterholm, who serves on the Advisory Board, told me. “We have no room to be wrong about this. None. We can be wrong about other things. If smallpox got out, it would be unfortunate, but it has a fourteen-day incubation period, it’s easy to recognize, and we would stop it. Much the same is true with SARS. But with flu you are infectious before you even know you are sick. And when it gets out it is gone. Those researchers have all of our lives at the ends of their fingers.”
http://www.newyorker.com/magazine/2012/03/12/the-deadliest-virus
Bird Infections with Highly-Pathogenic Avian Influenza A (H5N2), (H5N8), and (H5N1) Viruses: Recommendations for Human Health Investigations and Response
...
Vaccination
No human vaccines for HPAI (H5N1), (H5N2), or (H5N8) are available in the United States. Efforts are underway to develop vaccines against these HPAI H5 viruses. Seasonal influenza vaccines do not provide any protection against human infection with HPAI H5 viruses.
http://emergency.cdc.gov/han/han00378.asp
NanoViricides, Inc. - FluCide(TM)
The Company believes that its FluCide™ drug candidate will be effective against most if not all influenza viruses, including the H7N9 bird flu, H3N2 or H1N1 epidemic viruses, H5N1 bird flu, seasonal influenzas, as well as novel influenza viruses. This is because FluCide is based on the Company’s biomimetic technology, mimicking the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide® polymeric micelle. It is important to note that all influenza viruses bind to the sialic acid receptors, even if they rapidly mutate. The FluCide drug candidates have already shown strong effectiveness against H1N1 and H3N2 influenza viruses in highly lethal animal models. The injectable FluCide drug candidate has shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care, in a highly lethal influenza infection animal model. The Company believes that these animal model results should translate readily into humans.
NanoViricides has also developed an oral drug candidate against influenza. This oral version was found to be dramatically more effective than oseltamivir (TamiFlu®) in animals given a highly lethal level of influenza virus infection. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth.
Read more:
http://finance.yahoo.com/news/nanoviricides-president-dr-diwan-presented-120000451.html
http://www.prnewswire.com/news-releases/nanoviricides-provides-an-update-on-its-progress-over-the-last-quarter-300061129.html
...
The data indicates that both NV-INF-1 and NV-INF-2 are highly effective, broad-spectrum, anti-influenza drugs. The Company has shown that they are effective against both group I and group II influenza A viruses.
Dr. Diwan also reported that the Company is successfully scaling up production of NV-INF-1 for the GLP Safety/Toxicology study at its current facilities. In addition, he reported that construction of the Company’s new facility capable of cGMP production of all of the Company’s nanoviricides drug candidates for human clinical batches is now complete. Facility testing and validation are in progress.
...
No failures in 5000 plus animals and...
"...we don't anticipate any in humans because remember, we are agnostic to the host...we don't care if you are a man, a mouse, a whale, or a salamander. As long as you have a virus in your circulation, we destroy it!"~ Dr. Eugene Seymour, CEO of NanoViricides, Inc.
We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.
USA (HPAI H5N2)
The World Organization for Animal Health (OIE)'s Director General Bernard Vallat said that the avian influenza epidemic is likely to be under control within a few months as the United States has increased measures to contain the disease and the summer heat weakens it. The virus has led to the death or culling of more than 40 million birds from commercial farms and backyard flocks in 16 states. The epidemic was particularly severe in the U.S. because farmers were not prepared, and because of the large size of the nation's farms.
http://www.nwhc.usgs.gov/disease_information/avian_influenza/
Company blames heat for why nasal spray flu vaccine didn't work well in kids against swine flu
4/21/2015 - A live virus nasal flu vaccine known as FluMist (made by AstraZeneca) is failing to provide protection to children, and its manufacturer is blaming the vaccine's total inefficacy on high temperatures rather than exaggerated quack science. When the supposedly "fragile" shot is set out at room temperature...
http://www.edmontonjournal.com/health/Company+blames+heat+nasal+spray+vaccine+didnt+work+well+kids/10845059/story.html
Brain-Damaged UK Victims of Swine Flu Vaccine to Get £60 Million Compensation
4/20/2015 - The swine flu vaccine caused severe brain damage in over 800 children across Europe, and the UK government has now agreed to pay $90 million in compensation to those victims as part of a vaccine injury settlement. This is the same swine flu vaccine that the entire mainstream media ridiculously insists...
http://www.ibtimes.co.uk/brain-damaged-uk-victims-swine-flu-vaccine-get-60-million-compensation-1438572
"Canadian Flu vaccine paradox" Admits vaccines are causing more illness
3/5/2015 - The conventional medical system is literally grasping at straws trying to maintain the illusion that vaccines work, with new reports now admitting that flu vaccines are an utter failure while still pushing people to get them. The latest nonsensical narrative, at least from the Canadian government, attributes...
See more at: http://www.thedailysheeple.com/canadian-flu-vaccine-paradox-admits-vaccines-are-causing-more-illness_012015#sthash.eKmnlsK6.dpuf
Government pays compensation to 80 flu vaccine injuries and deaths
1/7/2015 - (Republished from VaccineImpact.com) The December 2014 report from the Department of Justice on damages paid by the U.S. Government to vaccine victims was recently published by the U.S. Department of Health and Human Resources. There were 180 cases of vaccine injuries decided. 134 cases received compensation,...
http://www.VaccineImpact.com
Flu cases spiking across US following CDC admission that this year's flu vaccine doesn't work
1/2/2015 - The vaccine industry is once again pimping the mainstream media to be its marketing mouthpiece for this year's flu "season," with the latest reports claiming that more than half of the country is now seeing a major uptick in flu cases. This year's influenza vaccine admittedly doesn't work against...
http://www.cbsnews.com/news/flu-outbreak-spreading-rapidly-in-us/
[Is there any chance that "Pump Terminator" or other bogeymen ever did risk assesment for any of them vaccine/drug companies, the competition for our small company, NanoViricides, Inc.? Of course, we are now reading about the aftermath, about damaged or ended lives, not your family but, what about these companies before they went to market? Any risk assesment on them companies? What is the risk assesment on your investment for any drug/vaccine company that gets "juiced up" and afforded shortcuts by a government? Ask "Pump Terminator" and good luck with that. Ask Zincy and good luck with that too! I'm sure the lives of some good folks have been hurt or ended by them "Great Society" governments "juiced up" companies. It is all about good intentions, right? And the latest, trust but verify! Verify, when again? And there's winners and there's losers - But they ain't no big deal -
'Cause the simple man, baby - Pays for thrills - The bills the pills that kill...
You vs. Big Government and Big Pharma
Big Pharma is a huge, out of control special interest group that derives its power and influence from its partner, Big Government. You see, government bureaucrats profit from promoting Big Pharma, because of the legions of lobbyists employed to help write the laws, the regulators who intensely review and follow every drug development and the politicians who are always looking for a big campaign donor.
On the far left, folks like Michael Moore attack this arrangement as capitalism, but really it is socialist corporatism-a partnership between Big Government and Big Pharma to promote the interests of each other at the costs of anyone who gets in the way.
http://www.offthegridnews.com/alternative-health/you-vs-big-government-and-big-pharma/
[Yes, Big Pharma and other smaller favorites of Big Government types. Greased skids or shortcuts, anyone? So easy to trade stocks with "greased skids"]
Big Pharma
Big Pharma is the nickname given to the world's vast and influential pharmaceutical industry and its trade and lobbying group, the Pharmaceutical Research and Manufacturers of America or PhRMA. These powerful companies make billions of dollars a year by selling drugs and medical devices.
....
The industry demonstrates its power, political might and social influence over the nation’s governments and agencies, its health care systems, its doctors and hospitals, as well as the psyche of the American people. With the help of staggering profits and 1,100-plus paid lobbyists, the industry has gained powerful leverage on Capitol Hill.
From 1998 to 2013, Big Pharma spent nearly $2.7 billion on lobbying expenses — more than any other industry and 42 percent more than the second highest paying industry: insurance. And since 1990, individuals, lobbyists and political action committees affiliated with the industry have doled out $150 million in campaign contributions.
http://www.drugwatch.com/manufacturer/
[Of course they have to spend a lot of money to buy lawmakers influence! After all, many human lives will be destroyed. How does Big Government, the largest investment organization in the history of mankind (investment, hah!) with US $18+ trillion (or is it $28 trillion, or is it $38 trillion, or is it...???) in the hole and counting at the speed of compound interest on the debt!!!...How does Big Government - DoD tells a company here is $140 million "hot check"; go do some Ebola drug research/development? Another display of "Yes we can" socialist/democrat corporatism? Or how does the DoD spends $400 million on smallpox vaccine that God help us no one wants to be in a situation where they become the guinea pig to test a drug that theoretically should work!?! Where is the sense of proportionality? We are talking about a small company with a safe drug vs a juiced up company or juiced up Big Pharma? Just what is the criteria employed to select these drug companies? This is why Dr. Seymour is correct in saying, "...there are no shortcuts", definitely not for our small drug company and its disruptive technology. First of all, it has been found to be safe time and time again...]
http://www.fiercebiotech.com/press-releases/tekmira-awarded-140-million-u-s-government-contract-develop-rnai-therapeutic-against-is
http://www.forbes.com/sites/rickungar/2011/11/13/is-bizarre-smallpox-drug-deal-obama-administrations-next-solyndra/
...NNVC's FluCide is composed of : 1. A backbone of PEG that provides the polar outer shell of the micelle and makes it soluble 2. Pendant (branched chains) of fatty acids that provide the non-polar core (and likely disrupt the viral coat - my conjecture) 3. Sialic acid and other receptor (ligand) mimics that act as decoys to attract and bind the viral particles. Of these, only PEG is not naturally occurring, which is why we've been discussing its potential toxicity here. And as indicated in Winstreak's post, it is used extensively in drug products (and consumer products). And it has an excellent safety profile with an extremely wide band of tolerance.~ Robi-1-Kenobi and Winstreak
"...we don't anticipate any in humans because remember, we are agnostic to the host...we don't care if you are a man, a mouse, a whale, or a salamander. As long as you have a virus in your circulation, we destroy it!"~ Dr. Eugene Seymour, CEO of NanoViricides, Inc.
If true, what is wrong with internships to assist in cGLP - scale up production?
Research Associate Intern
Employee Type: Paid Internship; hours will vary between 20-40 hours per week
Location: Inovio Pharmaceuticals, Inc.
San Diego, CA Office - 11494 Sorrento Valley Road, San Diego, CA 92121
Reports to: Plasmid Production Scientist
Job Description:
We are currently expanding our research and development efforts and seeking a temporary (with the possibility of becoming full-time) Research Associate I Intern with a background in immunology, molecular or cell biology. The ideal candidate will not only meet the minimum and essential requirements, but can also work independently, solve complex problems, and master a spectrum of techniques in both basic cell and molecular biology and immunology including cell cultures and DNA preps.
Essential Job Functions:
DNA Purification
Gel Electrophoresis
Cell Cultures
Histology, IHC
Assist with ELiSA assays
Assist with animal experiments
Blood and tissue sampling
Present experimental results in departmental and/or company meetings
Adhere to corporate policies and SOPs
General lab duties such as reagents prep, stocking of supplies, cleaning, shipping and receiving
Documentation and record keeping
Drive between different work locations within San Diego
Minimum Requirements:
BS or currently a college senior in the biological sciences, preferably in immunology, cell or molecular biology, or bioengineering
Laboratory knowledge
Essential Requirements:
Experience in aseptic/GLP techniquess
Willingness to work with animals; experience in animal handling a plus
Attention to detail, ability to prioritize and handle multiple projects
Proficiency in MS Office applications
Excellent organizational and written/oral communication skills
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.
Inovio Pharmaceuticals offers an attractive benefits package and is an Equal Opportunity Employer. Current US work authorization is required.
For consideration, please send your resume and a concise cover letter describing your qualifications to: careers@inovio.com with “SD RA I Intern” in the subject line.
http://www.inovio.com/company/careers/research-associate-i-intern/
=======================================
Developmental scale-up for new biopharmaceuticals
...our Biological Characterization Group has now completely moved to our Shelton, CT campus. We are implementing a phased move to Shelton so that there is minimal impact on our continuing operations. We plan on continuing to use our West Haven facility to maximize R&D efforts on our large number of drug development programs.
In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.
Narrow Nanoparticle Distribution
Uniformity of particle size is equally important in process performance. Microfluidizer® homogenization equipment excels at generating the narrowest particle size distribution results possible, thanks to stable pressure and constant volume processing at pressures up to 40,000 pounds per square inch. This leads to improved product stability and extended shelf life – and may significantly improve yield of active ingredients post filtration/sterilization to reduce costs associated with production.
Guaranteed Scalability
Attaining unprecedented particle size reduction and a uniform distribution is one thing, but scalability is often another. We guarantee seamless scale-up with unique parallel path micro-channel architecture to achieve consistent process performance and repeatable results; not only from batch to batch, but also from lab environments to pilot and production facilities.
Scale-up of the FluCide™ anti-influenza drug candidate is progressing well. We are continuing the CMC studies (see below) on FluCide production processes. These studies are necessary to enable further scale-up from the current multi-100g scale of production to kg-scale production of our nanoviricides drug candidates. The 1kg-scale production is being set up at our new Shelton, CT facility and headquarters.
...
We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.
We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.
We are happy to announce that our Biological Characterization Group has now completely moved to our Shelton, CT campus. We are implementing a phased move to Shelton so that there is minimal impact on our continuing operations. We plan on continuing to use our West Haven facility to maximize R&D efforts on our large number of drug development programs.
http://www.wdrb.com/story/28727617/nanoviricides-provides-an-update-on-its-progress-over-the-last-quarter
==============================================
About Microfluidics and Nanofluidics...
Scaleup with Repeatable Results
Achieving results in the lab is a critical step, but for most commercial applications it is only valuable if the results can be reproduced in a production environment. Every model in the Microfluidics product line is engineered with the end result in mind. By utilizing a linear scaleup method of the fixed-geometry interaction chambers, customers using Microfluidizer processors in the lab are guaranteed to attain the same repeatable and predictable results when scaling up to production volumes.
http://www.microfluidicscorp.com/applications/biotechnology/52
...
Of course, achieving success in the lab is only valuable it can be repeated reliably, regardless of scale. Microfluidics further differentiates from other technologies in that not only are results repeatable from batch to batch, but also from lab environments to pilot and production volumes. This is achieved by aligning microchannels in parallel within the interaction chamber, with a a single output reservoir. This essentially ensures the entire product stream experiences identical shear, resulting in consistent quality no matter the volume, from 1 mL (with the new LV1 low volume machine) up to 60 liters-per-minute.
http://www.microfluidicscorp.com/our-technology/how-it-works
New Alliance Between Microfluidics And Particle Sciences Expands Reach Of Microfluidizer® Technology
Microfluidics and Particle Sciences collaborate to extend the application, expertise and support of unique high shear fluid processors.
[4/06/2015] — Westwood, MA — Microfluidics, exclusive global creator of Microfluidizer® high shear fluid processors, is now partnering with Particle Sciences, Inc., a leading contract development and manufacturing organization (CDMO). This new alliance is designed to give the companies more ways to serve their clients with complex formulation development as well as lab support testing services in Pharmaceutical and Biopharmaceutical processing.
“Particle Sciences has been a good partner in the past, making our decision to work more closely with them an easy one,” said Brad Besse, Business Unit Director at Microfluidics. “They have shown themselves to be leaders in nanoparticle production, specifically with our technology.”
...
CEO at Particle Sciences, Dr. Mark Mitchnick, added, “Particle Sciences is the leading CDMO for nano-based products. We have worked with Microfluidics since before their acquisition by IDEX, and already have several machines installed. We are seeing an increasing need for the highly consistent performance Microfluidizer® technology is able to deliver. This, combined with Particle Sciences’ deep understanding of the technology and our base capabilities in characterization and sterile production is driving the relationship expansion. We have formulated multiple products with Microfluidizer® technology, recently manufacturing 120L of a sterile emulsion for a client using the equipment and have several more in the pipeline.”
Besse also said he believes “that by working together, both parties can expand their application expertise and support services to better serve our customer needs. In addition to formulation and clinical trial production, Particle Sciences affords our customers the ability to work with highly potent compounds under cGMP guidelines, in a purpose-built facility.”
http://www.microfluidicscorp.com/latest-news-a-events/200-new-alliance-between-microfluidics-and-particle-sciences-expands-reach-of-microfluidizerr-technology
NanoViricides, Inc. is in the process of commissioning operations at the new cGMP Pilot Plant facility in order to perform the scale up studies needed for making the large quantities of FluCide materials in a controlled manner. These upcoming studies will be performed in cGLP compliant manner to provide safety and toxicology data that are required for an IND submission to regulatory agencies. The Validation/Qualification definition emphasizes product; the Commissioning def. emphasizes equipment.
...
We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.
http://www.prnewswire.com/news-releases/nanoviricides-files-quarterly-report-for-period-ending-2015-03-31-300084664.html
And if the nanoviricides(R) are bioequivalent, once you get the scale-up recipe for FluCide(TM), the recipe for other nanoviricides(R) won't be far off, or will they?
=============================================
About Microfluidics and Nanofluidics...
Scaleup with Repeatable Results
Achieving results in the lab is a critical step, but for most commercial applications it is only valuable if the results can be reproduced in a production environment. Every model in the Microfluidics product line is engineered with the end result in mind. By utilizing a linear scaleup method of the fixed-geometry interaction chambers, customers using Microfluidizer processors in the lab are guaranteed to attain the same repeatable and predictable results when scaling up to production volumes.
http://www.microfluidicscorp.com/applications/biotechnology/52
...
Of course, achieving success in the lab is only valuable it can be repeated reliably, regardless of scale. Microfluidics further differentiates from other technologies in that not only are results repeatable from batch to batch, but also from lab environments to pilot and production volumes. This is achieved by aligning microchannels in parallel within the interaction chamber, with a a single output reservoir. This essentially ensures the entire product stream experiences identical shear, resulting in consistent quality no matter the volume, from 1 mL (with the new LV1 low volume machine) up to 60 liters-per-minute.
http://www.microfluidicscorp.com/our-technology/how-it-works
New Alliance Between Microfluidics And Particle Sciences Expands Reach Of Microfluidizer® Technology
Microfluidics and Particle Sciences collaborate to extend the application, expertise and support of unique high shear fluid processors.
[4/06/2015] — Westwood, MA — Microfluidics, exclusive global creator of Microfluidizer® high shear fluid processors, is now partnering with Particle Sciences, Inc., a leading contract development and manufacturing organization (CDMO). This new alliance is designed to give the companies more ways to serve their clients with complex formulation development as well as lab support testing services in Pharmaceutical and Biopharmaceutical processing.
“Particle Sciences has been a good partner in the past, making our decision to work more closely with them an easy one,” said Brad Besse, Business Unit Director at Microfluidics. “They have shown themselves to be leaders in nanoparticle production, specifically with our technology.”
...
CEO at Particle Sciences, Dr. Mark Mitchnick, added, “Particle Sciences is the leading CDMO for nano-based products. We have worked with Microfluidics since before their acquisition by IDEX, and already have several machines installed. We are seeing an increasing need for the highly consistent performance Microfluidizer® technology is able to deliver. This, combined with Particle Sciences’ deep understanding of the technology and our base capabilities in characterization and sterile production is driving the relationship expansion. We have formulated multiple products with Microfluidizer® technology, recently manufacturing 120L of a sterile emulsion for a client using the equipment and have several more in the pipeline.”
Besse also said he believes “that by working together, both parties can expand their application expertise and support services to better serve our customer needs. In addition to formulation and clinical trial production, Particle Sciences affords our customers the ability to work with highly potent compounds under cGMP guidelines, in a purpose-built facility.”
http://www.microfluidicscorp.com/latest-news-a-events/200-new-alliance-between-microfluidics-and-particle-sciences-expands-reach-of-microfluidizerr-technology
Micro & Nano Technology
Particle Sciences has been at the forefront of drug delivery related fine-particle and nanotechnology formulation since the early 1990s. We provide a wide range of particulate fabrication and drug product preparation services. Our efforts have resulted in commercial products including nanoparticles scaled to as much as half a million kilos per year. Whether it's Particle Sciences' proprietary technology or conventional systems, our staff knows how to apply these tools to meet your needs.
The incorporation of an API into a particle can take many forms. Possibilities range from an emulsion droplet to any number of encapsulation systems to a Lyocell® to a nanoparticle of the API itself. These various formats cover a range of sizes from tens of microns down to several nanometers, each providing their own utility with respect to any given API. Reasons for using a nanoparticle or larger particulate can include:
Incorporation of difficult to solubilize APIs
Controlling bioavailability
Controlling drug/excipient interaction
Improving API stability
Targeted delivery
Controlling uniformity
Taste masking
Altering pharmacokinetic and toxicological profiles
Intellectual property
Lifecycle management
Having a full range of technologies and the needed equipment provides us with options assuring that the best solution for our client is achieved. Our particle & nanoparticle engineering expertise includes, among others, micronized particulates (eg jet-milling), spray drying, emulsions, suspensions, liposomes, LyoCells®, solid lipid nanoparticles, polymer nanoparticles, PEGPLUS™, coacervates and polyelectrolyte complexes, and micro/nano capsules.
Our micro/nanoparticle fabrication labs are supported by in-house cGMP/cGLP analytic facilities and ICH stability testing programs. We can seamlessly bring your product into the clinic, producing clinical trial materials and commercial supplies. We have worked with small molecules, oligonucleotides, peptides, proteins and carbohydrates. We are FDA registered and DEA licensed for all scheduled substances.
http://www.particlesciences.com/services/micro-nano-technology/
A Problem-Free Life is a Fantasy Not Worth Feeding
This work situation reminds me of Jonathan Fields’ recent interview with Garden Cafe founder and owner Bart Potenza. Potenza has flourished in the hyper-competitive New York City restaurant field for 25 years with his signature vegan restaurant. And what does Potenza think about most hours of the work day?
About equipment. Whether or not the restaurant equipment will fail at the last minute and compromise customers’ dining experience.
Fantasizing about a problem-free, suffering-free life is a trap for aspiring creatives. If you’re prone to escape problems, avoid the creative life.
- See more at: http://www.creativitypost.com/create/the_problem_solving_paradox_of_creativity#sthash.zHMbWchg.dpuf
[It doesn't matter what kind of business you are in, the creative embrace complexity. Scientists embrace complexity to solve problems and some of NanoViricides, Inc. new hires are likely involved in that particular process. No reason to fret about this or BASi. BASi has 40 plus years of experience in the business and I am sure they embrace complexity as well.]
PEG has a toxicological profile of very low concern and is well tolerated at high doses after chronic and acute administration. The PEG associated with a biological molecule itself should provide no extra concern because the toxicity versus exposure relationship in animals and humand has been thoroughly investigated and metabolism/excretion is well understood. Based on the comparisons of PEG exposure from PEGylated biological products and the exposures of PEG associated with toxicity, the therapeutic index is large (=600-fold). The metabolism of PEG is limited to metabolic modification of the hydroxyl group, and the data available suggest that the metabolites seen in humans are seen in animals. Also, for PEGs typically used on biologicals, metabolism will not play a major role in PEG elimination. In light of these data, PEG metabolites do not represent a significant issue, especially when combined with the low overall exposure to PEG discussed above.
Studying the metabolism of PEGylated biologics will represent a significant challenge. First, radiolabeling of PEG associated with a biological molecule is not a viable option. Second, the doses of these PEGylated biologicals are usually very low. Third, PEG is present in a range of products that humans are routinely exposed to. The detection of trace exposures of PEG metabolites produced from PEGylated biologicals will be impossible against the background of PEG and its metabolites present as a result of routine exposure. Moreover, because the products of metabolism are the same regardless of the route of administration, because metabolism represents a minor route of clearance, and because data demonstrate that PEG exposures considerably higher than those possible from PEGylated biologicals are required for toxicity, any additional experiments seem unjustified and of very limited value.
The data presented in this article indicate that, assuming toxicological evaluation of a biological molecule of interest is completed in an appropriate species and satisfactory therapeutic windows are achieved, the PEG associated with a protein or other biological molecule does not represent a significant additional unquantified risk to humans, because of 1) the low exposures involved, 2) the low toxicity profile of PEG, and 3) the similarity of the metabolites that are formed in all species.
Further studies to elucidate the metabolism of the PEG associated with a biological molecule in humans will not provide any more information to place into context the safety of PEG, and such studies may not even be possible. http://dmd.aspetjournals.org/content/35/1/9.full
[Bets on margin need to be concerned with facts that were presented at the 3rd Annual Influenza Research and Development.]
West Haven, Conn.--(BUSINESS WIRE)--
NanoViricides, Inc. (NYSE MKT:NNVC) (the “Company”) reports that its President, Dr. Anil Diwan, was invited to present the FluCide™ data at the 3rd Annual Influenza Research and Development Conference on Friday, July 11, at 0850 am. The Conference ran from July 9-11 at the Hyatt Regency in Boston, MA, and was held by GTC Bio (https://www.gtcbio.com/conferences/influenza-research-and-development-agenda).
Dr. Diwan discussed the nanoviricides® technology platform, and presented the pre-clinical data on the Company’s first drug candidate, NV-INF-1, Injectable FluCide™, to treat all influenza infections in hospitalized patients. Influenza A H1N1 infected animals treated with FluCide survived the full 21-day observation period, whereas animals treated with 40mg/kg/d oseltamivir phosphate (Tamiflu®) survived only 8 days in this highly lethal study. Influenza A/WS/33/ (H1N1) virus was used in this study. The highly lethal infectious dose of 1M viral particles at time 0 h followed by another 1M virus particles at 23h that was employed caused uniform lethality in 5 days in untreated mice. Body weight began to decline in the infected, untreated mice, by days 2-3 days and continued to decline until death. The Oseltamivir-treated mice maintained body weight only through day 5, which declined thereafter until death. Similar to the survival results, the mice treated with NV-INF-1 maintained their body weight substantially longer, through day 14. NV-INF-1 demonstrated an unparalleled 1,000-fold reduction in lung viral load compared to untreated animals on day 4 in this lethal animal model study. Moreover, the lung viral load was suppressed to this baseline level through 13 days or longer, with a slight increase on day 19. In contrast, the current standard of care, oseltamivir, (Tamiflu®, Roche) exhibited only a 2-fold reduction in lung viral load at day 4, that rapidly rose by approximately 2X on day 7. Similar to the reduced virus titers, on day 4 the lungs from mice that were treated with NV-INF-1 showed a substantially lower lung weight (healthy) and displayed a markedly reduced presence of virus-induced lesions as compared to the untreated control and oseltamivir. Also similar to lung virus titers, the reductions in lung lesions in animals treated with NV-INF-1 were maintained at least through 13 days.
Dr. Diwan also discussed the extremely high safety of NV-INF-1 observed in preliminary safety/toxicology studies. He noted that no significant changes in all observed parameters were found even at the maximum feasible dose of approximately 2,700 mg/kg/d repeatedly given for five consecutive days.
He also presented the data on NV-INF-2, the Company’s current oral anti-influenza drug candidate. NV-INF-2 has the same antiviral ligand as NV-INF-1, but a different polymeric backbone that has enabled significant oral effectiveness. NV-INF-2 has been evaluated in a mouse model of influenza virus infection using two different influenza virus a strains, A/WS/33/ (H1N1) and A/W/67 (H3N2v). NV-INF-2 treated mice survived as long as 14.5 days in an H1N1 lethal infection study, and for 15.6 days in an H3N2 lethal infection study. Oseltamivir treated animals died in only 7.6 days in H1N1 infection study, and in 9.6 days in the H3N2 study. The lethal infection viral dose and protocol was chosen such that the untreated animals died in 5 days in both H1N1 and H3N2 studies. Similar to substantially increased survival, NV-INF-2 also exhibited substantially superior reduction in lung viral titer and protection of lungs from lesions.
The data indicates that both NV-INF-1 and NV-INF-2 are highly effective, broad-spectrum, anti-influenza drugs. The Company has shown that they are effective against both group I and group II influenza A viruses.
Dr. Diwan also reported that the Company is successfully scaling up production of NV-INF-1 for the GLP Safety/Toxicology study at its current facilities. In addition, he reported that construction of the Company’s new facility capable of cGMP production of all of the Company’s nanoviricides drug candidates for human clinical batches is now complete. Facility testing and validation are in progress.
The market size for an effective influenza drug for treating severely ill hospitalized patients has been estimated in the billions of dollars, worldwide, depending upon the therapeutic value and cost savings. Currently, there is no effective therapeutic available for this indication. The Company believes that it could supply a substantial portion of the demand for this drug from its new small scale cGMP clinical drug facility. This drug is currently in IND-enabling studies.
This broad-spectrum FluCide drug is expected to work against most, if not all, forms of influenza virus, including epidemic, pandemic (e.g. H1N1/2009), high path influenzas such as H3N2, H7N9, and “bird flu” such as H5N1.
The total market size addressed by the Company’s current drug programs is estimated at about $50 billion. In addition to Injectable FluCide, the Company is working on five more commercially important drug candidates, namely: DengueCide™, HerpeCide™, HIVCide™, Oral FluCide™ for out-patients, and a broad-spectrum antiviral drug for viral diseases of the external eye. All of our programs are for therapeutics to treat viral infections. Our drugs are expected to be useful as prophylactics as well. DengueCide has recently received orphan drug designation by the US FDA as well as the European EMA.
Read more: http://finance.yahoo.com/news/nanoviricides-president-dr-diwan-presented-120000451.html
[And today those are the undisputed F-A-C-T-S. Our anti-influenza drugs are independent from the host's immune system. NanoViricides, Inc. therapeutic drugs are only targeting the life-threatening virus in the host.]
No failures in 6000 plus animals and...
"...we don't anticipate any in humans because remember, we are agnostic to the host...we don't care if you are a man, a mouse, a whale, or a salamander. As long as you have a virus in your circulation, we destroy it!"~ Dr. Eugene Seymour, CEO of NanoViricides, Inc.
NanoViricides, Inc. is in the process of commissioning operations at the new cGMP Pilot Plant facility in order to perform the scale up studies needed for making the large quantities of FluCide materials in a controlled manner. These upcoming studies will be performed in cGLP compliant manner to provide safety and toxicology data that are required for an IND submission to regulatory agencies. The Validation/Qualification definition emphasizes product; the Commissioning def. emphasizes equipment.
...
We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.
http://www.prnewswire.com/news-releases/nanoviricides-files-quarterly-report-for-period-ending-2015-03-31-300084664.html
And if the nanoviricides(R) are bioequivalent, once you get the scale-up recipe for FluCide(TM), the recipe for other nanoviricides(R) won't be far off, or will they?
=============================================
About Microfluidics and Nanofluidics...
Scaleup with Repeatable Results
Achieving results in the lab is a critical step, but for most commercial applications it is only valuable if the results can be reproduced in a production environment. Every model in the Microfluidics product line is engineered with the end result in mind. By utilizing a linear scaleup method of the fixed-geometry interaction chambers, customers using Microfluidizer processors in the lab are guaranteed to attain the same repeatable and predictable results when scaling up to production volumes.
http://www.microfluidicscorp.com/applications/biotechnology/52
...
Of course, achieving success in the lab is only valuable it can be repeated reliably, regardless of scale. Microfluidics further differentiates from other technologies in that not only are results repeatable from batch to batch, but also from lab environments to pilot and production volumes. This is achieved by aligning microchannels in parallel within the interaction chamber, with a a single output reservoir. This essentially ensures the entire product stream experiences identical shear, resulting in consistent quality no matter the volume, from 1 mL (with the new LV1 low volume machine) up to 60 liters-per-minute.
http://www.microfluidicscorp.com/our-technology/how-it-works
[Published online Mar 2013...]
4.2 Microfluidic methods
Microfluidics, the science and technology of manipulating nanoliter volumes in microscale fluidic channels, has shown that several labour-intensive and time-consuming steps such as sample preparation, mixing, reactions, purification, separations, and detection could be performed on a single monolithic microfabricated device.238 In the last few years, applications of microfluidics have expanded from conventional chemical and biological analysis to other fields such as chemical reactions, biochemical assays, and cell handling.239 Two particularly important contributions have been the development of soft lithography in PDMS as a method for fabricating prototype devices, and the simple fabrication of pneumatically activated valves, rapid mixers and pumps on the basis of soft-lithographic procedures. This has resulted in the fabrication of prototype devices to test new ideas in approximately 2 days (from design to working device), whereas the same applications for silicon technology may take a month ormore for non-specialists to carry out.With respect to nanoparticles, the ability of microfluidic systems to mix reagents rapidly, provide homogenous reaction environments, continuously vary reaction conditions, enable rapid temperature control, and allow addition of reagents at precise time intervals—are some of the key features that have made microfluidic systems useful for the synthesis of NPs.240 Furthermore, synthesis carried out in microchannels allows for in-line characterization,241 feedback control,242 and high-throughput continuous synthesis,243 which potentially enables screening and optimization of libraries of nanoparticles with different properties.
Recently, technologies developed for the synthesis of polymeric NPs have demonstrated the tremendous potential for microfluidics to dramatically improve on current bulk synthesis methods. Polymeric NPs prepared by bulk synthesis tend to have variable physicochemical properties (size, surface composition, and drug loading) due to the inability to control the mixing of precursors.236 Further post-processing by extrusion, freeze–thaw, sonication, and/or high-pressure homogenization is often required. Using rapid mixing techniques in micro-channels such as hydrodynamic flow focusing, polymeric NPs exhibiting narrow size distributions compared to bulk synthesis have been prepared in a reproducible manner (Fig. 4).236, 237 In these systems size can be tuned by either varying the mixing time of precursors, which is achieved by varying the flow ratio of the precursor streams, by varying the molecular weight of the polymer, or by simply varying the concentration of the polymer in the organic solution. Remarkably, for polymeric NPs prepared through microfluidics, higher drug encapsulation without increase in NP size has been observed,236 which is highly desired for therapeutic NPs. Another method to prepare NPs takes advantage of the rapid mixing microenvironment that occurs in micro-droplets formed inside microfluidic channels.244 For instance, cross-linked alginate NPs were synthesized in a micro-channel using aqueous alginate droplets as templates, followed by the shrinkage of the drops. This method exhibited remarkable control over the NP properties, specifically size and size distribution. These are just a few examples showing the advantages of microfluidics for nanoparticle synthesis, and recent reviews discuss these concepts further.240, 245 Given the volume of research currently involving the microfluidic synthesis of NPs, it is expected that as more therapeutic NPs reach a clinical stage, the need for improved synthesis methods would also increase, at which point microfluidic technologies could likely become an important tool in their development of NPs.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3684255/
WEST HAVEN, Conn., Feb. 25, 2015 /PRNewswire
NanoViricides Files Quarterly Report for Period Ending 2014-12-31
...
In addition, the Company is performing process development and scale up studies on its FluCide drug candidate. FluCide is designed as a treatment for influenza in seriously ill hospitalized patients, a potentially fatal disease for which no satisfactory treatment exists. FluCide's excellent safety profile resulted in the need for a very large quantity of the drug for the GLP Safety/Toxicology studies required for an Investigational New Drug ("IND") filing. The multi-kilogram quantities of FluCide needed for these safety and toxicology studies will be produced in the new Shelton facility.
http://www.prnewswire.com/news-releases/nanoviricides-files-quarterly-report-for-period-ending-2014-12-31-300041185.html
NanoViricides Provides an Update on Its Progress over the Last Quarter
Influenza
We are currently working to increase the production of FluCide™, our anti-influenza drug candidate. FluCide has been designed for use in hospitalized patients with complicated influenza. FluCide was found to be extremely safe in preliminary toxicology studies in mice and rats. As a result of the extreme safety finding, it was estimated that about 2.5kg of drug substance would be needed for the complete large animal toxicology studies. These studies are needed for filing an Investigational New Drug Application (IND). In mice, no adverse events were observed even at doses as high as 480 mg/kg/d repeated on five days (a total of 2,400 mg/kg), when given intraperitoneally. Similar strong safety was also observed in the initial part of the formal toxicology study in rats. In rats, no adverse events were observed with doses as high as 300mg/kg/d given by rapid intravenous infusion, and repeated for 14 days (a total of 4,200 mg/kg). We are in the process of producing a total of 2.5kg of FluCide for the final large animal toxicology studies. Our toxicology studies are being performed by BioAnalytical Systems, Inc. (BASI) of Indiana (BASI).
We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.
We are happy to announce that our Biological Characterization Group has now completely moved to our Shelton, CT campus. We are implementing a phased move to Shelton so that there is minimal impact on our continuing operations. We plan on continuing to use our West Haven facility to maximize R&D efforts on our large number of drug development programs.
http://www.reuters.com/article/2015/04/06/nanoviricides-updates-idUSnPn7fzXxL+85+PRN20150406
On Monday, April 27, 2015
NanoViricides Discusses the Strong Effectiveness of Its Anti-Herpes Drug Candidates in a Lethal Animal Model of Dermal Herpes Infection
...
In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.
http://www.prnewswire.com/news-releases/nanoviricides-files-quarterly-report-for-period-ending-2015-03-31-300084664.html
NanoViricides Files Quarterly Report for Period Ending 2015-03-31
...
Scale-up of the FluCide™ anti-influenza drug candidate is progressing well. We are continuing the CMC studies (see below) on FluCide production processes. These studies are necessary to enable further scale-up from the current multi-100g scale of production to kg-scale production of our nanoviricides drug candidates. The 1kg-scale production is being set up at our new Shelton, CT facility and headquarters.
...
The Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analytics Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility. We implemented a phased program for commissioning the new facility. This has enabled us to continue to progress in all of our existing programs, without interruptions.
...
The Company believes that the drug approval process for a topical herpes treatment could be relatively rapid, based on the strong effectiveness results. The Company intends to meet with its FDA advisory consulting group, namely, Biologics Consulting Group, Inc., to chart out the path towards approval. In addition, the Company intends to engage a Contract Research Organization (CRO) for further development of a topical anti-herpes drug into the regulatory approval pathway for US FDA as well as internationally. The Company intends to study various indications including HSV-1 cold sores, HSV-2 genital lesions, Herpes keratitis (an eye disease), and Shingles, among other possibilities.
The market size for herpes virus treatments is in excess of $2 billion annually. The Company believes that a drug that is superior to existing therapies could result in significantly expanded market size, as has been demonstrated in the case of HIV, Hepatitis C and other diseases. An estimate of over $40 billion for an effective anti-herpes drug may not be excessive, considering the near-complete penetration of the various herpesviruses in human population, and the repetitive and debilitating nature of illnesses that they can cause.
...
We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.
http://www.prnewswire.com/news-releases/nanoviricides-files-quarterly-report-for-period-ending-2015-03-31-300084664.html
And if the nanoviricides(R) are bioequivalent, once you get the scale-up recipe for FluCide(TM), the recipe for other nanoviricides(R) won't be far off, or will they?
=============================================
Scaleup with Repeatable Results
Achieving results in the lab is a critical step, but for most commercial applications it is only valuable if the results can be reproduced in a production environment. Every model in the Microfluidics product line is engineered with the end result in mind. By utilizing a linear scaleup method of the fixed-geometry interaction chambers, customers using Microfluidizer processors in the lab are guaranteed to attain the same repeatable and predictable results when scaling up to production volumes.
http://www.microfluidicscorp.com/applications/biotechnology/52
When posting about Pump Terminator (PT) what is implied or suggested by their actions is that he/she/them are a low-down, lying kind. That is all. He/she/they don't like how the company is managed, and just for the sake of causing damage, PT in his over-inflated sense of self worth believes that great minds can only come from ivy league colleges/universities with Ph.D.s. Titles and acolades help but it was not the case with Tesla. Read more here about (6) uneducated Amateurs whose genius changed the world. http://www.cracked.com/article_19248_6-uneducated-amateurs-whose-genius-changed-world.html
Did Dr. Anil Diwan's discovery and development of nanoviricides begin through serendipity? While testing the nanomicelle as a future therapeutic courier, Diwan and company ran a Proof-of-Concept against a massive virus particle, cytomegalovirus, biggest virus to give the nanomicelle a huge target. After applying the nanomicelles to the culture, they found no virus. Couldn't figure it out because there was not yet an Active Pharmaceutical Ingredient in the micelle...the nanomicelle destroyed virus particles every single time a virus particle came in contact... -BigKahuna. True? Ask Dr. Diwan. Who else would you ask, an anonymous poster that claims his slur, his libelous/defamatory blog, is protected by his/their Freedom of Speech - First Ammendment. The New York U.S. Court of Law at their discretion ruled the blog was protected but based on the results on other cases before U.S. Courts of Law across the U.S. they ruled wrong.
Pump Terminator(PT) was not interested in the truth, legal or otherwise. He/she/they were on a hit job and wanted to cause damage to our property/stock price and he/she/they did. But in the interest of truth, legal or otherwise, the sociopath(s)/psychopath(s) should have come out of the shadows and face his/hers/their victims/the damaged party, NanoViricides, Inc. and stockholders. PT should have stated: Here are my/our claims and here is my proof!
PT was too busy blogging falsehoods, half truths, lies, all from a place in the shadows, all under the cover of Freedom of Speech!?!
Examples of defamation/libel cases:
A judge has rejected a request from the widow of Chris Kyle, the author or “American Sniper,” to order a new trial or set aside a jury’s verdict in favor of former Gov. Jesse Ventura of Minnesota, who was awarded $1.8 million in a defamation claim against Mr. Kyle. Mr. Ventura said Mr. Kyle made up a claim of punching Mr. Ventura at a California bar in 2006 after the former governor supposedly made offensive comments about Navy SEALs. Lawyers for Mr. Kyle’s wife, Taya, argued that the laws and evidence at trial did not support the jury’s award. Judge Richard H. Kyle of Federal District Court, who also presided over that trial, wrote in a decision filed Wednesday that the trial was fair and the verdict supported by “substantial evidence.” Mr. Kyle was considered the deadliest sniper in United States military history. He was killed in Texas last year.
A version of this brief appears in print on November 27, 2014, on page A26 of the New York edition with the headline: Minnesota: Ventura’s Defamation Award Upheld.
http://www.nytimes.com/2014/11/27/us/minnesota-venturas-defamation-award-upheld.html?ref=topics&_r=0
Detroit News Loses Libel Case
By United Press International | September 6, 1985
A former owner of the Pine Knob entertainment complex won a $3 million libel suit against the Detroit News. A jury in Wayne County Circuit Court announced the award Wednesday after two days of deliberations. Gary Francell claimed in his suit that four Detroit News stories falsely linked him and co-owner Joseph Locricchio to organized crime. Although both Francell and Locricchio sued the newspaper, only Francell was awarded damages. Their lawyer, Jeremiah Kenney, said jurors declined...
http://articles.chicagotribune.com/1985-09-06/business/8502280312_1_libel-jury-detroit
'Anonymous' Posters to Pay $13 Million for Defamatory Comments
Internet Service Provider Cooperated to Provide Information Leading to Suspected Identity of Topix Commenters
By KI MAE HEUSSNER and SUSANNA KIM
April 24, 2012 —
A Texas couple who filed a defamation lawsuit over three years ago against anonymous posters on the Internet forum Topix.com won a $13.8 million judgment from a jury.
Mark and Rhonda Lesher of Clarksville, Texas, filed a suit against anonymous commenters who accused them of being sexual deviants, molesters, and drug dealers on Topix, once self-described as "the country's largest local forum site."
"This vindicates us. This is vindication for all the scurrilous, vile, defamatory statements that caused us to be indicted, to be tried, that caused us to move out of town and my wife to lose her business," Mark Lesher said, the Texarkana Gazette reported. "You can't post anonymous lies on the Internet without suffering the consequences."
http://abcnews.go.com/Business/jury-awards-13-million-texas-defamation-suit-anonymous/print?id=16194071
PT slurs, defamatory, libelous, criminal blog should not be claimed to be protected by Freedom of Speech - First Ammendment if he/she/they cannot stand in person before a U.S. Court Law to defend their half-truths, falsehoods, claims, right next to the party that was damaged, NanoViricides, Inc./stockholders. It is all about "The Law" and being able to face our accusers before a U.S. Court of Law. We were the damaged party and we were there.
=========================================
16.11
"Apparently," I said to him, "you care nothing for the public, for Malthus, for the truth, for conscience, or for yourself."
16.12
This is the way an opinion gains acceptance in France. Fifty ignoramuses repeat in chorus some absurd libel that has been thought up by an even bigger ignoramus; and, if only it happens to coincide to some slight degree with prevailing attitudes and passions, it becomes a self-evident truth. ~ Frederic Bastiat
Your post is "incomplete, incorrect," and lacking in context." I don't see proof of your claims. My first question: how many candidates did NanoViricides, Inc. ship to USAMRIID? Did they ship 18, 24, etc.? This is the most recent news PR we got from NanoViricides, Inc. on Ebola:
Ebola
Using NanoViricides's rapid design platform, it took only 4 months from design to synthesis of the multiple EbolaCide drug candidates needed for study. In late January, these novel anti-Ebola drug candidates were sent to our collaborating BSL-4 facility for initial testing. Our drug candidates were found to be broad-spectrum, in that they were equally effective against Ebola virus as well as Marburg viruses. This is unlike the antibody-based, siRNA-based and antisense-based anti-Ebola therapeutics currently being advanced, which only work against specific strains with a very narrow and selective spectrum of activity. Broad-spectrum activity of our drug candidates is a very important and valuable characteristic, as it indicates that mutations of the virus in the field are unlikely to cause escape of the virus from our final EbolaCide™ drug. We believe that with the new insight we have gained, and with our experience from earlier studies, we can continue to optimize our multiple drug candidates before another Ebola epidemic strikes. The recent outbreak in Africa, though now waning, has unequivocally demonstrated the need for an effective, broad-spectrum, anti-Ebola therapeutic in order to control any further outbreaks.
http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Provides%20an%20Update%20on%20Its%20Progress%20over%20the%20Last%20Quarter.html
Before we get to a final Ebola candidate (singular) we will be reading about Ebola candidates (plural) as we did for FluciDe(TM).
NanoViricides Reports FluCide™ Drug Candidates Found to Offer Significant Reduction in Damaging White Blood Cell Presence
http://www.nanoviricides.com/press%20releases/2011/NanoViricides%20Reports%20FluCide%20Drug%20Candidates.html
Both the oral and the injectable FluCide drug candidates have shown extremely high effectiveness in highly lethal mouse models of two distinctly different influenza A virus infections, viz. H1N1 and H3N2, indicating that FluCide drugs indeed have a broad-spectrum effect against influenza viruses, irrespective of the subtype or strain.
In these highly lethal studies, FluCide drug candidates have achieved complete survival (22+ days), while in contrast, Tamiflu® (oseltamivir) resulted in only 8-9 days survival, and the untreated animals die within 5 days. The FluCide oral and injectable drug candidates also protected the lungs of the animals much better than did oseltamivir, indicating a clear benefit. The protection from influenza virus was clearly reflected in the strong increase in survival time in the FluCide-treated animals as compared to oseltamivir. The FluCide drugs were seen to be far superior to Tamiflu also in terms of viral load reduction. The FluCide drugs were extremely well tolerated, in contrast to oseltamivir. No dose-limiting side effects have been seen for our FluCide candidates as yet, indicating that in a severely ill patient, the dosage of FluCide can be increased even further. In these animal studies, the mouse serves only as a “test tube” and FluCide is designed to attack the virus (not the host). Thus the results are expected to correlate well with the impending human clinical studies.
http://www.nanoviricides.com/press%20releases/2013/NanoViricides%20Anticipates%20FluCide%E2%84%A2%20Drug%20Candidates%20to%20be%20Effective%20Against%20H7N9.html
Where do you get it was a dud? Try to be more credible and cite your sources!
=======================================
Ebola Virus: Film reveals scenes of horror in Liberia - BBC News
A virus can change itself to less deadly, but more contagious and that's something we are afraid of
Dr Anavaj Sakuntabhai, Geneticist
The facts were presented at the 3rd Annual Influenza Research and Development.
West Haven, Conn.--(BUSINESS WIRE)--
NanoViricides, Inc. (NYSE MKT:NNVC) (the “Company”) reports that its President, Dr. Anil Diwan, was invited to present the FluCide™ data at the 3rd Annual Influenza Research and Development Conference on Friday, July 11, at 0850 am. The Conference ran from July 9-11 at the Hyatt Regency in Boston, MA, and was held by GTC Bio (https://www.gtcbio.com/conferences/influenza-research-and-development-agenda).
Dr. Diwan discussed the nanoviricides® technology platform, and presented the pre-clinical data on the Company’s first drug candidate, NV-INF-1, Injectable FluCide™, to treat all influenza infections in hospitalized patients. Influenza A H1N1 infected animals treated with FluCide survived the full 21-day observation period, whereas animals treated with 40mg/kg/d oseltamivir phosphate (Tamiflu®) survived only 8 days in this highly lethal study. Influenza A/WS/33/ (H1N1) virus was used in this study. The highly lethal infectious dose of 1M viral particles at time 0 h followed by another 1M virus particles at 23h that was employed caused uniform lethality in 5 days in untreated mice. Body weight began to decline in the infected, untreated mice, by days 2-3 days and continued to decline until death. The Oseltamivir-treated mice maintained body weight only through day 5, which declined thereafter until death. Similar to the survival results, the mice treated with NV-INF-1 maintained their body weight substantially longer, through day 14. NV-INF-1 demonstrated an unparalleled 1,000-fold reduction in lung viral load compared to untreated animals on day 4 in this lethal animal model study. Moreover, the lung viral load was suppressed to this baseline level through 13 days or longer, with a slight increase on day 19. In contrast, the current standard of care, oseltamivir, (Tamiflu®, Roche) exhibited only a 2-fold reduction in lung viral load at day 4, that rapidly rose by approximately 2X on day 7. Similar to the reduced virus titers, on day 4 the lungs from mice that were treated with NV-INF-1 showed a substantially lower lung weight (healthy) and displayed a markedly reduced presence of virus-induced lesions as compared to the untreated control and oseltamivir. Also similar to lung virus titers, the reductions in lung lesions in animals treated with NV-INF-1 were maintained at least through 13 days.
Dr. Diwan also discussed the extremely high safety of NV-INF-1 observed in preliminary safety/toxicology studies. He noted that no significant changes in all observed parameters were found even at the maximum feasible dose of approximately 2,700 mg/kg/d repeatedly given for five consecutive days.
He also presented the data on NV-INF-2, the Company’s current oral anti-influenza drug candidate. NV-INF-2 has the same antiviral ligand as NV-INF-1, but a different polymeric backbone that has enabled significant oral effectiveness. NV-INF-2 has been evaluated in a mouse model of influenza virus infection using two different influenza virus a strains, A/WS/33/ (H1N1) and A/W/67 (H3N2v). NV-INF-2 treated mice survived as long as 14.5 days in an H1N1 lethal infection study, and for 15.6 days in an H3N2 lethal infection study. Oseltamivir treated animals died in only 7.6 days in H1N1 infection study, and in 9.6 days in the H3N2 study. The lethal infection viral dose and protocol was chosen such that the untreated animals died in 5 days in both H1N1 and H3N2 studies. Similar to substantially increased survival, NV-INF-2 also exhibited substantially superior reduction in lung viral titer and protection of lungs from lesions.
The data indicates that both NV-INF-1 and NV-INF-2 are highly effective, broad-spectrum, anti-influenza drugs. The Company has shown that they are effective against both group I and group II influenza A viruses.
Dr. Diwan also reported that the Company is successfully scaling up production of NV-INF-1 for the GLP Safety/Toxicology study at its current facilities. In addition, he reported that construction of the Company’s new facility capable of cGMP production of all of the Company’s nanoviricides drug candidates for human clinical batches is now complete. Facility testing and validation are in progress.
The market size for an effective influenza drug for treating severely ill hospitalized patients has been estimated in the billions of dollars, worldwide, depending upon the therapeutic value and cost savings. Currently, there is no effective therapeutic available for this indication. The Company believes that it could supply a substantial portion of the demand for this drug from its new small scale cGMP clinical drug facility. This drug is currently in IND-enabling studies.
This broad-spectrum FluCide drug is expected to work against most, if not all, forms of influenza virus, including epidemic, pandemic (e.g. H1N1/2009), high path influenzas such as H3N2, H7N9, and “bird flu” such as H5N1.
The total market size addressed by the Company’s current drug programs is estimated at about $50 billion. In addition to Injectable FluCide, the Company is working on five more commercially important drug candidates, namely: DengueCide™, HerpeCide™, HIVCide™, Oral FluCide™ for out-patients, and a broad-spectrum antiviral drug for viral diseases of the external eye. All of our programs are for therapeutics to treat viral infections. Our drugs are expected to be useful as prophylactics as well. DengueCide has recently received orphan drug designation by the US FDA as well as the European EMA.
Read more: http://finance.yahoo.com/news/nanoviricides-president-dr-diwan-presented-120000451.html
[And today those are the undisputed F-A-C-T-S. Currently there is no company out there, none, that has pre-clinical data for a highly effective and broad-spectrum anti-influenza drugs. Moreover, our anti-influenza drugs are independent from the host's immune system. Our drugs are only targeting the life-threatening virus in the host.]
No failures in 6000 plus animals and...
"...we don't anticipate any in humans because remember, we are agnostic to the host...we don't care if you are a man, a mouse, a whale, or a salamander. As long as you have a virus in your circulation, we destroy it!"~ Dr. Eugene Seymour, CEO of NanoViricides, Inc.
We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.
The problem is that they are really hard to make. Even though they are small [molecules] they are very complex and it usually takes a highly trained specialist and a long time ~ Dr. Martin Burke...[but not anymore...a 3d printer-like molecule-making machine is here, now, and that is a fact!]
NanoViricides, Inc. has tested Flucide(TM) candidates (plural) with third party collaborators to come up with their most advanced, low toxicity, host immune system independent, effective, anti-influenza type A candidate capable of broad protection against existing and/or new strains. Can any company out there match Flucide(TM) capabilities? Can any other company come up with a therapeutic drug or vaccine that will embody all aforementioned powerful characteristics into one? The answer is NO. At this point in time only NanoViricides, Inc. can and I am certain will deliver these drugs to market. Just like the Peabody ducklings march, it will be one therapeutic drug after the other thanks to new modifications for large quantities/scale up to the facility.
"The pace of development of our broad drug pipeline is now accelerating due to the strong financing we have been able to raise concomitant with our up-listing to the NYSE-MKT exchange," said Anil R. Diwan, PhD, President.
In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.
A new company, co-founded by Burke, called REVOLUTION Medicines, Inc. has already licensed the technology and is investing heavily in developing next generation molecule-making machines which will be much more powerful and easier to scale.
[Does anyone know of a company that is at the stage NanoViricides, Inc. is, just about ready to accelerate/produce large quantities of their most advanced Flucide(TM) candidate?]
Influenza
We are currently working to increase the production of FluCide™, our anti-influenza drug candidate. FluCide has been designed for use in hospitalized patients with complicated influenza. FluCide was found to be extremely safe in preliminary toxicology studies in mice and rats. As a result of the extreme safety finding, it was estimated that about 2.5kg of drug substance would be needed for the complete large animal toxicology studies. These studies are needed for filing an Investigational New Drug Application (IND). In mice, no adverse events were observed even at doses as high as 480 mg/kg/d repeated on five days (a total of 2,400 mg/kg), when given intraperitoneally. Similar strong safety was also observed in the initial part of the formal toxicology study in rats. In rats, no adverse events were observed with doses as high as 300mg/kg/d given by rapid intravenous infusion, and repeated for 14 days (a total of 4,200 mg/kg). We are in the process of producing a total of 2.5kg of FluCide for the final large animal toxicology studies. Our toxicology studies are being performed by BioAnalytical Systems, Inc. (BASI) of Indiana (BASI).
We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.
We are happy to announce that our Biological Characterization Group has now completely moved to our Shelton, CT campus. We are implementing a phased move to Shelton so that there is minimal impact on our continuing operations. We plan on continuing to use our West Haven facility to maximize R&D efforts on our large number of drug development programs.
Drug Pipeline
The Company has six commercially important drug development programs in its rich pipeline. These include (i) Injectable FluCide for hospitalized patients, (ii) Oral FluCide™ for out-patients with Influenza, (iii) broad spectrum HerpeCide™ for various forms of herpes virus infections that cause oral and genital herpes, herpes keratitis (eye disease), and possibly also chickenpox, and shingles, (iv) a broad-spectrum antiviral ophthalmic solution for viral diseases of the eye such as epidemic kerato-conjunctivitis (EKC, caused usually by adenoviruses), and herpes keratitis, (v) DengueCide™, a broad-spectrum drug against all four types of dengue viruses, and (vi) HIVCide™, a broad-spectrum anti-HIV drug candidate that may be a "functional cure" against HIV/AIDS. In addition, we are engaged in research programs for the development of broad-spectrum drug candidates against a number of other viruses. These include filoviruses such as Ebola and Marburg, Rabies, and many others. We continue to advance these programs as opportunities become available. In the past, we have been constrained by the limitation of our small laboratory R&D facility in West Haven, CT. We now have a 18,000 sq. ft. state of the art cGMP-capable manufacturing facility for clinical scale production of any of our nanomedicine dug candidates including injectables, located in Shelton, CT. We are now working to bring the facility into full-scale operation. We anticipate that this facility will dramatically expand our ability to move our drug candidates into a clinical stage pipeline.
The Company has previously announced that it had approximately $36.4 Million (M) of current assets plus restricted cash (cash, cash equivalents, collateral advance, prepaid expenses, and security deposits) as of December 31, 2014. The Company's operating expenditure is approximately $2M per quarter. We believe that we have sufficient funding available to perform initial human clinical studies on at least one of our drug candidates, and possibly to bring at least one other drug candidate into IND stage.
http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Provides%20an%20Update%20on%20Its%20Progress%20over%20the%20Last%20Quarter.html
[What is that company drug that directly competes with broad spectrum, low toxicity and effective Flucide(TM)? Tamiflu???...]
Different bird flu strain detected in Indiana backyard flock
Originally published May 11, 2015 at 1:10 pm
It is a different strain than the virus that has led to the loss of more than 30 million chickens, turkeys and other birds since March in 13 states.
The Associated Press
COLUMBIA CITY, Ind. (AP) — Bird flu has been found in a backyard poultry flock in northeastern Indiana, and it’s the first time the specific strain in question has been detected in the central U.S., animal health officials said Monday.
The H5N8 virus found in Whitley County is different from the H5N2 virus that has led to the loss of more than 30 million chickens, turkeys and other birds since March in 13 states, including Minnesota and Wisconsin, the U.S. Department of Agriculture said.
Some birds in the Whitley County flock of 77 ducks, geese, chickens, turkeys and other species have died, the agency said. The remaining birds were removed, the Indiana State Board of Animal Health said.
The board said it was checking with nearby poultry owners to see if the disease has spread. The board said it is coordinating with the USDA, the Indiana State Poultry Association and the Indiana Animal Disease Diagnostic Laboratory in responding to the disease.
Indiana is a leading poultry-producing state, nationally ranked first in the production of ducks and fourth in turkeys.
The board encourages backyard poultry owners to watch for signs of bird flu and report illnesses and deaths to the U.S. Department of Agriculture. Signs include sudden death, lack of energy or appetite, decreased and misshapen egg production; nasal discharge, coughing, sneezing and diarrhea.
Bird flu doesn’t affect the safety of eating eggs or poultry and poses little risk to humans. No human infections with the virus have been detected, the USDA said.
Bird flu can be carried by free-flying waterfowl such as ducks, geese and shorebirds. The occurrence in Whitley County west of Fort Wayne is the first time the H5N8 strain has been detected in the Mississippi flyway for migrating birds over the central U.S. The H5N8 strain previously had only been confirmed in the Pacific flyway after being detected in Oregon and Washington.
The Associated Press
http://www.seattletimes.com/seattle-news/health/different-bird-flu-strain-detected-in-indiana-backyard-flock/
H5N8 is a subtype of the Influenza A virus (sometimes called bird flu virus). Although H5N8 is considered one of the lower pathogenic subtypes, it is beginning to become more so. Many times, H5N8 is used as an incubator for the highly pathogenic H1N1. [1]
http://www.seattletimes.com/seattle-news/health/different-bird-flu-strain-detected-in-indiana-backyard-flock/
Influenza A virus subtype H5N8
http://en.wikipedia.org/wiki/Influenza_A_virus_subtype_H5N8
NanoViricides, Inc. Reports Oral FluCide™ Is Highly Effective Against H3N2 Influenza A Virus and Superior to Tamiflu® based on Increased Survival in a Lethal Influenza Animal Model
...
The Company has recently established oral effectiveness of its anti-influenza drug candidates in an H1N1 influenza A lethal infection mouse model. The Company believes that this may be the first ever targeted nanomedicine that is orally effective.
The Company intends to develop data about effectiveness of its drug candidates against certain unrelated influenza A viruses using both cell culture studies and animal models in a reasonable manner. These data will be needed as part of the IND application that the Company is working on. An IND application will be required for the Company to enter into human clinical trials.
H3N2 influenza virus is one of the multiple sub-types of influenza A that cause seasonal epidemics. According to the CDC, influenza causes approximately 36,000 deaths every year in the U.S. alone. The Hong Kong Flu pandemic of 1968-1969, which killed an estimated one million people worldwide, was caused by a variant strain of H3N2. The Company believes an orally administered nanoviricide that protect against multiple influenza virus sub-types would be effective in season after season of influenza epidemics. Such a highly effective, broad-spectrum anti-influenza drug is widely anticipated to be highly successful.
The Company believes that the anti-influenza drug candidates it has developed are broad-spectrum, i.e. they should work against most if not all of influenza viruses. This is because, in spite of mutations and antigenic drift, all influenza viruses bind to the same cell surface receptor called sialic acid, and the Company has developed small chemical ligands that mimic this receptor, to attack the influenza viruses. These ligands are chemically attached to the Company’s polymeric micelle backbones that mimic the cell membrane, to create the nanoviricides. The Company has previously shown effectiveness of its very early anti-influenza drug candidates against two different strains of H5N1 Bird Flu virus in cell culture studies. The Company has since then improved the ligands as well as the chemistries as reported from time to time.
http://www.businesswire.com/news/home/20120924005450/en/NanoViricides-Reports-Oral-FluCide%E2%84%A2-Highly-Effective-H3N2#.VVHuG_DSMSU
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A Molecule-Making Machine
Leif, I agree. It is important to note where we've been and how we are about to accelerate development and large scale production of the cides.
H5N2 is a subtype of the species Influenzavirus A (avian influenza virus or bird flu virus). The subtype infects a wide variety of birds, including chickens, ducks, turkeys, falcons, and ostriches. Affected birds usually do not appear ill, and the disease is often mild as avian influenza viral subtypes go. Some variants of the subtype are much more pathogenic than others, and outbreaks of "high-path" H5N2 result in the culling of thousands of birds in poultry farms from time to time. It appears that people who work with birds can be infected by the virus, but suffer hardly any noticeable health effects. Even people exposed to the highly pathogenic H5N2 variety that killed ostrich chicks in South Africa only seem to have developed conjunctivitis, or a perhaps a mild respiratory illness. There is no evidence of human-to-human spread of H5N2.
http://en.wikipedia.org/wiki/Influenza_A_virus_subtype_H5N2
DNR reports 1st case of H5N2 bird flu in wild bird
Snowy owl in Oconto found to have disease
http://www.channel3000.com/news/dnr-reports-1st-case-of-h5n2-bird-flu-in-wild-bird/32884922
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The way the machine works is quite extraordinary. It is able to break down very complex molecules into their basic chemical building blocks. To put things into perspective, imagine each chemical building block as a different LEGO brick. They all share the same connectors, but may be totally different from one another. The machine is able to use a catch-and-release method to automate the process of connecting these building blocks together, one brick at a time, while releasing the byproducts of each chemical reaction. It was this technique of releasing the unwanted byproducts which made this breakthrough a reality. Using this process the machine can utilize over 200 different building blocks along with thousands of other molecules to ‘print’ billions of different organic compounds, many of which make up 14 classes of small molecules, including the ratanhine molecule family. Also, according to Burke, it can even synthesize chemicals which were never before created by human beings.
“The vision for the future is that anyone who needs a specific small molecule can essentially print it out from their computer,” explained Burke. “We are really excited about the immediate impacts that this will have on drug discovery.”
Magnus1, I think you and many other longs posting on this board, will agree that the most important step at this time is to accelerate development and large scale production of the cides...
In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.
http://www.streetinsider.com/Corporate+News/NanoViricides+%28NNVC%29+Updates+on+Significance+of+Anti-Viral+Drug+Candidates+in+Dermal+Herpes/10490266.html
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“We wanted to take a very complex process, chemical synthesis, and make it simple,” explained Burke. “Simplicity enables automation, which, in turn, can broadly enable discovery and bring the substantial power of making molecules to nonspecialists.”
The flu is linked to between 3,000 and 49,000 deaths and 200,000 hospitalizations each year in the United States. The seasonal flu vaccine was created to try to avert these epidemics.
Read more: http://www.webmd.com/cold-and-flu/flu-guide/advanced-reading-types-of-flu-viruses
Of great clinical significance is the fact that 2 of the optimized FluCide™ drug candidates maintained this greatly reduced lung viral load at 7, 13 and 19 days after virus infection in this 21 day study. Thus, treatment with FluCide drug candidates appeared to protect against the complete cycle of infection, virus expansion and spread of infection in the lungs that follows the initial virus infection. This was not the case for the oseltamivir-treated animals. Animals treated with Oseltamivir (Tamiflu®, Roche) showed less than a 2-fold reduction in lung viral load at 4 days and the viral load was increased at 7 days to the same level as that found in the infected, untreated control animals shortly before their death.
...
http://www.fiercebiotech.com/press-releases/treatment-nanoviricides-flucide-drug-candidates-resulted-1000-fold-reductio
[NanoVircides, Inc. now has its most developed anti-influenza therapeutic drug candidate, broad spectrum and low-toxicity]
Influenza
We are currently working to increase the production of FluCide™, our anti-influenza drug candidate. FluCide has been designed for use in hospitalized patients with complicated influenza. FluCide was found to be extremely safe in preliminary toxicology studies in mice and rats. As a result of the extreme safety finding, it was estimated that about 2.5kg of drug substance would be needed for the complete large animal toxicology studies. These studies are needed for filing an Investigational New Drug Application (IND). In mice, no adverse events were observed even at doses as high as 480 mg/kg/d repeated on five days (a total of 2,400 mg/kg), when given intraperitoneally. Similar strong safety was also observed in the initial part of the formal toxicology study in rats. In rats, no adverse events were observed with doses as high as 300mg/kg/d given by rapid intravenous infusion, and repeated for 14 days (a total of 4,200 mg/kg). We are in the process of producing a total of 2.5kg of FluCide for the final large animal toxicology studies. Our toxicology studies are being performed by BioAnalytical Systems, Inc. (BASI) of Indiana (NASDAQ: BASI).
We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.
We are happy to announce that our Biological Characterization Group has now completely moved to our Shelton, CT campus. We are implementing a phased move to Shelton so that there is minimal impact on our continuing operations. We plan on continuing to use our West Haven facility to maximize R&D efforts on our large number of drug development programs.
http://www.prnewswire.com/news-releases/nanoviricides-provides-an-update-on-its-progress-over-the-last-quarter-300061129.html
Cost of Flu Season
...
The cost of a flu season in lives lost, medical expenses and economic impact can be severe.
"In the United States of America, for example, recent estimates put the cost of influenza epidemics to the economy at US$ 71-167 billion per year."[27]
What Are the Different Types of Flu?
There are three types of flu viruses: A, B, and C. Type A and B cause the annual influenza epidemics that have up to 20% of the population sniffling, aching, coughing, and running high fevers. Type C also causes flu; however, type C flu symptoms are much less severe.
The flu is linked to between 3,000 and 49,000 deaths and 200,000 hospitalizations each year in the United States. The seasonal flu vaccine was created to try to avert these epidemics.
What Is Type A Flu Virus?
Type A flu or influenza A viruses are capable of infecting animals, although it is more common for people to suffer the ailments associated with this type of flu. Wild birds commonly act as the hosts for this flu virus.
Type A flu virus is constantly changing and is generally responsible for the large flu epidemics. The influenza A2 virus (and other variants of influenza) is spread by people who are already infected. The most common flu hot spots are those surfaces that an infected person has touched and rooms where he has been recently, especially areas where he has been sneezing.
What Is Type B Flu Virus?
Unlike type A flu viruses, type B flu is found only in humans. Type B flu may cause a less severe reaction than type A flu virus, but occasionally, type B flu can still be extremely harmful. Influenza type B viruses are not classified by subtype and do not cause pandemics.
Read more: http://www.webmd.com/cold-and-flu/flu-guide/advanced-reading-types-of-flu-viruses
With bird flu threat expected to linger...
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WHY PRODUCERS WANT A VACCINE
USDA officials have said the H5N2 virus could be a problem for the poultry industry for several years. The virus had already killed or led authorities to order the culling of nearly 2.3 million turkeys before it was confirmed Monday at an Iowa egg-laying operation with 3.8 million hens. And on Tuesday and Wednesday, five more turkey farms with more than 500,000 birds were added to the list.
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WHY THE USDA MIGHT DECIDE AGAINST A VACCINE
Introducing a vaccine raises a lot of questions, Myers said, including which poultry would get it, in what kind of settings, whether it would be effective in stopping the disease and potential negative effects on poultry exports.
James Sumner, president of the Georgia-based USA Poultry and Egg Export Council, said some countries might regard vaccine use as a reason to bar imports from the U.S. The vaccine could mask any viruses that poultry are carrying, because tests for the disease look for antibodies — the same antibodies that vaccines trigger a body to produce, he said.
Dr. Kyoungjin Yoon, an avian influenza expert at Iowa State University, said human experience shows flu vaccines don't always match well with viruses in circulation. Vaccine-induced immunity could also slow the detection of outbreaks, Yoon said. One of the main symptoms is that flocks start dying off quickly.
Read more: http://www.usnews.com/news/business/articles/2015/04/22/with-bird-flu-spreading-usda-starts-on-potential-vaccine
Treatment with NanoViricides FluCide™ Drug Candidates Resulted in a 1000-fold Reduction of Viral Load in the Lungs of Animals
...
The amount of infectious virus in the lungs of the infected animals treated with three of the optimized FluCide™ nanoviricide drug candidates was reduced by greater than 1000-fold as compared to the infected untreated control animals (p-values < 0.001), four days after virus infection. In contrast, animals treated with Oseltamivir (Tamiflu®, Roche) showed less than a 2-fold reduction in lung viral load at the same time point. This indicated a 500-fold greater reduction in viral load by FluCide drug candidates over Oseltamivir.
Of great clinical significance is the fact that 2 of the optimized FluCide™ drug candidates maintained this greatly reduced lung viral load at 7, 13 and 19 days after virus infection in this 21 day study. Thus, treatment with FluCide drug candidates appeared to protect against the complete cycle of infection, virus expansion and spread of infection in the lungs that follows the initial virus infection. This was not the case for the oseltamivir-treated animals. Animals treated with Oseltamivir (Tamiflu®, Roche) showed less than a 2-fold reduction in lung viral load at 4 days and the viral load was increased at 7 days to the same level as that found in the infected, untreated control animals shortly before their death.
...
http://www.fiercebiotech.com/press-releases/treatment-nanoviricides-flucide-drug-candidates-resulted-1000-fold-reductio
"We are agnostic to the host...we don't care if you are a man, a mouse, a whale or a salamander, as long as you have a virus in your system, we destroy it."~ Dr. Eugene Seymour, CEO NanoViricides, Inc.
[I figure that the decision to build/buy the new Shelton cGMP Pilot Plant was based in part by assurances from the bioreactor(s)vendor that scale up would be easier than it has been so far. Dr. Seymour has characterized scale up as a laborious process at the Shelton new cGMP Pilot Plant however, large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Currently various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.]
We just change the receptor molecule that's attached to our nanomicelle and now we're set up for another virus.
http://www.onemedplace.com/blog/archives/11132
A nanoviricide is created by chemically attaching a virus-binding ligand, derived from the binding site of the virus on its cell surface receptor, to a nanomicelle flexible polymer. This binding site does not change significantly when a virus mutates
Tailor-made design and selection of (1) the virus-binding ligand; and (2) the backbone "nanomicelle", separately, allows us to rapidly optimize drug candidates (a) against a number of viruses; (b) for desired pharmacokinetic characteristics (e.g. sustained effect); and (c) for different routes of administration. This versatility is unmatched in the Industry.
http://www.nanoviricides.com/technology.html
NanoViricides Reports that it is Evaluating Purchase of the New Facility and cGMP Pilot Production Plant instead of a Lease
"By 2011, when Dr. Diwan went all out and bought the Controls Drive property, we had spent several years searching for a third party contract manufacturer, capable of producing our drug candidates under the rigorous standards required for clinical trials, without success," said Eugene Seymour, MD, MPH, adding, "NanoViricides continued to search for available contract manufacturing capability even after Diwan's purchase of the Controls Drive property. Most facilities we interviewed could not manufacture our novel polymer molecules without extensive renovations. The cost of such custom renovations and equipment would be passed on to us, as is customary. In addition, we would have to train their technicians and scientists and transfer important know how and other aspects of our intellectual property."
http://www.nanoviricides.com/press%20releases/2014/NanoViricides%20Reports%20that%20it%20is%20Evaluating%20Purchase%20of%20the%20New%20Facility%20and%20cGMP%20Pilot%20Production%20Plant%20instead%20of%20a%20Lease.html
NanoViricides, Inc. Completes Purchase of cGMP-compliant Pilot Production Facility
NanoViricides now intends to move its operations to the new facility in a phased manner in order to minimize any potential impact on ongoing projects. The Company expects to manufacture its drug candidates for human clinical trials at the new facility. The Company further reports that all of its drug development programs are progressing satisfactorily.
...
The 18,000 sqft building at 1 Controls Drive, Shelton, CT, was completely renovated in order to build a modern, state-of-the-art c-GMP-compliant manufacturing facility for the production of clinical scale quantities of a wide variety of injectable nanomedicines drug substances and drug products, modern nanomedicines research and development facilities, as well as an on-site state-of-the-art nanomedicines analysis and characterization facility. The new facility comprises a small office space, R&D Chemistry Labs, R&D Biology Labs, R&D Analytical Lab and cGMP supporting Analytical Lab, cGMP-compliant raw materials handling and dispensing area, and c-GMP compliant Clean Room Suites for nanomedicines production and product packaging processes. All of the R&D labs employ class 100,000 or cleaner air systems. The clean room suites comprise class 10,000 air quality areas as well as class 1,000 and the ultra-clean class 100 air quality areas (the class specifies the number of particles per 1,000 liters of air). This allows production and handling of nanomedicines with minimal risk of entraining foreign particles. All of the R&D labs employ deionized water. For critical processes, WFI-quality water is also produced on site in quantities needed to support the production scale (WFI = water for injection, comprises a specification of water quality that specifies minimal endotoxins and maximum sterility).
http://www.prnewswire.com/news-releases/nanoviricides-inc-completes-purchase-of-cgmp-compliant-pilot-production-facility-300017051.html
NanoViricides : Reports that the FluCide(R) Candidate was found to be Very Safe in cGLP-like Safety and Toxicology Study in Rats Performed by BASi
WEST HAVEN, Conn., Jan. 23, 2015 /PRNewswire/ -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company"), a nanomedicine company developing anti-viral drugs, reported a good safety profile of an optimized FluCideR drug candidate in a GLP-like toxicology study in rats. These results are extremely important since they indicate that FluCide continues to look very promising as one of the most advanced candidates in the Company's drug development pipeline.
...
No direct adverse clinical effects were found upon administration of the FluCide candidate intravenously at doses of up to 300mg/kg/day for 14 days (a total of 4,200mg/kg) in rats. Organs were examined for gross histological observations. Microscopic histological tissue analysis was also performed.
There were no adverse histological findings in gross organ level histological examination, nor were there any adverse findings in microscopic histological analysis. Equally importantly, there were no meaningful effects observed on animal weight gain, food consumption, hematology, or clinical chemistry at the end of the 14 day dosing period.
The study was conducted at BASi (Bioanalytical Systems, Inc., NASDAQ: BASI) in Evansville, Indiana. The study was performed in a cGLP-like fashion, compliant with BASi Evansville standard operating procedures. BASi has over 40 years of experience providing contract research services and niche instrumentation to the life sciences, primarily drug research and development.
These results are in agreement with the previously reported results of a non-GLP toxicology study in mice. The current study results also support the Company's positive findings in animal models of infection with different influenza A virus strains in which no safety or toxicology concerns were observed. The Company has previously reported that many of its FluCide candidates demonstrated extremely high anti-influenza activity in those models.
This study was developed in collaboration with BASi and conducted by BASi in a cGLP-like fashion in order to understand the safety parameters of FluCide intravenous dosing.
The next phase of the toxicology package studies will involve larger animals, and will require much larger quantities of the drug candidate. The Company is in the process of commissioning operations at the new 1 Controls Drive, Shelton, CT facility in order to perform the scale up studies needed for making the large quantities of materials in a controlled manner. These upcoming studies will be performed in cGLP compliant manner to provide safety and toxicology data that are required for an IND submission to regulatory agencies.
http://www.4-traders.com/NANOVIRICIDES-INC-15311537/news/NanoViricides--Reports-that-the-FluCide-Candidate-was-found-to-be-Very-Safe-in-cGLP-like-Safety-an-19751467/
"We wanted to take a very complex process, chemical synthesis, and make it simple," explained Burke. "Simplicity enables automation, which, in turn, can broadly enable discovery and bring the substantial power of making molecules to nonspecialists."
"The vision for the future is that anyone who needs a specific small molecule can essentially print it out from their computer," explained Burke. "We are really excited about the immediate impacts that this will have on drug discovery."
"by the way, I'm sure that when you think human trials for drugs you think of hundreds of millions of dollars and years of time, well in this case because the disease only lasts a week, two weeks,...that it is possible to complete human trials in the space of a few short months...four parts to the human trials" ~ Dr. Eugene Seymour, Nanoviricides, Inc.
Under 505b, tox for FluCide becomes tox for everything that follows. For the second tox following FluCide, they will only need to show bio-equivalence, that is, a bridge study would be required to demonstrate that a system processes EbolaCide, DengueCide, X-Cide, in the same way as FluCide. Since FluCide will most probably already be in clinical trials, the second and maybe third X-Cide for clinical trials will need only a bridge study in Phase 1 to advance to Phase 2/3, again that would be an abbreviated PK [Pharmacokinetics] study showing bio-equivalence in processing versions of nanomicelles.~ BigKahuna
"The pace of development of our broad drug pipeline is now accelerating due to the strong financing we have been able to raise concomitant with our up-listing to the NYSE-MKT exchange," said Anil R. Diwan, PhD, President.
"It is not easy to convey, unless one has experienced it, the dramatic feeling of sudden enlightenment that floods the mind when the right idea finally clicks into place. One immediately sees how many previously puzzling facts are neatly explained by the new hypothesis. One could kick oneself for not having the idea earlier, it now seems so obvious. Yet before, everything was in a fog." ~ Francis Crick, What Mad Pursuit
I neglected to add the following to my previous post, a PR which I'm sure you've read before.
NanoViricides Discusses the Strong Effectiveness of Its Anti-Herpes Drug Candidates in a Lethal Animal Model of Dermal Herpes Infection
...
SHELTON, Conn., April 27, 2015 /PRNewswire/ -- NanoViricides, Inc., (NYSE MKT: NNVC) (the "Company"), a nanomedicine company developing anti-viral drugs, discusses the significance of the strong effectiveness demonstrated by its anti-viral drug candidates in a lethal animal model of dermal herpes infection.
NanoViricides, Inc. recently reported that its anti-Herpes drug candidates demonstrated substantially complete survival of mice that were lethally infected with the HSV-1 H129c strain. In contrast, acyclovir, the standard of care drug, resulted in only a limited survival (less than 58%), even though it was employed at twice the human drug concentration. Further, the survival improvement correlated with the reduction in clinical disease scores, demonstrating significant reduction in disease severity.
These results are very significant considering that topical acyclovir in the form of a cream as well as an ointment are approved for the treatment of cold sores.
Our strong anti-herpes nanoviricide® drug candidates are capable of reaching approval as drug for topical use against herpes cold sores, the Company believes, based on these datasets. Further drug development is necessary towards the goal of drug approval.
The Company intends to meet with its FDA advisory consulting group, namely, Biologics Consulting Group, Inc., to chart out the path towards approval. In addition, the Company intends to engage a Contract Research Organization (CRO) for further development of a topical anti-herpes drug into the regulatory approval pathway for US FDA as well as internationally.
"A rapid drug approval process is possible for our anti-herpes nanoviricide® topical skin treatment," said Eugene Seymour, MD, MPH, "We intend to investigate the regulatory pathway and intend to put our anti-herpes drug candidates into the approval process as soon as feasible."
"The pace of development of our broad drug pipeline is now accelerating due to the strong financing we have been able to raise concomitant with our up-listing to the NYSE-MKT exchange," said Anil R. Diwan, PhD, President.
In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.
http://www.prnewswire.com/news-releases/nanoviricides-discusses-the-strong-effectiveness-of-its-anti-herpes-drug-candidates-in-a-lethal-animal-model-of-dermal-herpes-infection-300072282.html
So they have a warranty program from the vendor and I speculate the scale up will not be as laborious as it has been for months!
===========================================
"It is not easy to convey, unless one has experienced it, the dramatic feeling of sudden enlightenment that floods the mind when the right idea finally clicks into place. One immediately sees how many previously puzzling facts are neatly explained by the new hypothesis. One could kick oneself for not having the idea earlier, it now seems so obvious. Yet before, everything was in a fog." ~ Francis Crick, What Mad Pursuit
It all got on track about two years ago...
OneMedRadio: NanoViricides CEO Discusses U.S. Patent
May 2012
NanoViricides, Inc. (OTC BB: NNVC) recently announced that a fundamental patent, on which the nanoviricidesR technology is based was issued in the USA on May 8, 2012. The issuance notification was received from the US Patents and Trademarks Office last week.
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The US Patent is granted for "Solubilization and Targeted Delivery of Drugs with Self-Assembling Amphiphilic Polymers." The patent term is expected to last through October 1, 2026, including an anticipated extension, with the possibility of further extensions in compensation for time spent in clinical trials.
"We are very pleased with the validation of the novelty of our technologies," said Dr. Diwan, President and Chairman of NanoViricides, Inc., adding, "This patent establishes a fundamentally new direction in developing biomimetic approaches."
Commenting on the patent award, Dr. Eugene Seymour, MD, MPH, Chief Executive Officer of the company, stated, "We always knew that this is a ground-breaking technology. We believe, based on the tremendous effectiveness that our nanoviricides drugs have shown against a large number of viral diseases in several very stringent animal models, that this technology spells a fundamental change in how medicines will be developed in the future. For example, our anti-influenza clinical candidate, FlucideT, was developed using the nanoviricideR technology, and has exhibited surprisingly high levels of effectiveness in animal studies, far surpassing the existing drugs. Our expectation that FluCide will work well in humans is based upon the results of these animal studies that indicate (1) extremely high treatment effectiveness in inhibiting the cycle of infection, virus expansion and spread of infection and, (2) the significantly long lasting effects of the drug treatment even after the drug is discontinued."
Brett Johnson: So what do you see is the principal applications of this technology?
Dr. Eugene Seymour: Well, let's look at some of the more common viral diseases that have market shares in the billions. Influenza and our nanoviricide for influenza will destroy any influenza A and we've tested many, many different ones. We even tested H5N1 the bird flu virus. We tested that in Vietnam when they were having an outbreak some years ago. HIV and we reported some very good results in animals with HIV. In fact, we reported a functional cure on two separate occasions, which means that we reduced the level of virus in the body to such a low level that you allow the antibody producing cells to recover and control the remainder of the cells and that way people can live a normal life often as we anticipate with only five days of treatment and maybe an additional treatment every three months for the next year and then after that nothing. They're not contagious because the amount of virus that they have in the body is really so dramatically reduced. Then there's herpes of the genitals, herpes of the eye.
BJ: And this technology is effective on all these viruses?
ES: Yeah. All we do is change the receptor molecule. It's a plug and play. It's a Lego system.
We just change the receptor molecule that's attached to our nanomicelle and now we're set up for another virus.
http://www.onemedplace.com/blog/archives/11132
A nanoviricide is created by chemically attaching a virus-binding ligand, derived from the binding site of the virus on its cell surface receptor, to a nanomicelle flexible polymer. This binding site does not change significantly when a virus mutates
Tailor-made design and selection of (1) the virus-binding ligand; and (2) the backbone "nanomicelle", separately, allows us to rapidly optimize drug candidates (a) against a number of viruses; (b) for desired pharmacokinetic characteristics (e.g. sustained effect); and (c) for different routes of administration. This versatility is unmatched in the Industry.
http://www.nanoviricides.com/technology.html
NanoViricides Reports that it is Evaluating Purchase of the New Facility and cGMP Pilot Production Plant instead of a Lease
"By 2011, when Dr. Diwan went all out and bought the Controls Drive property, we had spent several years searching for a third party contract manufacturer, capable of producing our drug candidates under the rigorous standards required for clinical trials, without success," said Eugene Seymour, MD, MPH, adding, "NanoViricides continued to search for available contract manufacturing capability even after Diwan's purchase of the Controls Drive property. Most facilities we interviewed could not manufacture our novel polymer molecules without extensive renovations. The cost of such custom renovations and equipment would be passed on to us, as is customary. In addition, we would have to train their technicians and scientists and transfer important know how and other aspects of our intellectual property."
http://www.nanoviricides.com/press%20releases/2014/NanoViricides%20Reports%20that%20it%20is%20Evaluating%20Purchase%20of%20the%20New%20Facility%20and%20cGMP%20Pilot%20Production%20Plant%20instead%20of%20a%20Lease.html
NanoViricides, Inc. Completes Purchase of cGMP-compliant Pilot Production Facility
NanoViricides now intends to move its operations to the new facility in a phased manner in order to minimize any potential impact on ongoing projects. The Company expects to manufacture its drug candidates for human clinical trials at the new facility. The Company further reports that all of its drug development programs are progressing satisfactorily.
...
The 18,000 sqft building at 1 Controls Drive, Shelton, CT, was completely renovated in order to build a modern, state-of-the-art c-GMP-compliant manufacturing facility for the production of clinical scale quantities of a wide variety of injectable nanomedicines drug substances and drug products, modern nanomedicines research and development facilities, as well as an on-site state-of-the-art nanomedicines analysis and characterization facility. The new facility comprises a small office space, R&D Chemistry Labs, R&D Biology Labs, R&D Analytical Lab and cGMP supporting Analytical Lab, cGMP-compliant raw materials handling and dispensing area, and c-GMP compliant Clean Room Suites for nanomedicines production and product packaging processes. All of the R&D labs employ class 100,000 or cleaner air systems. The clean room suites comprise class 10,000 air quality areas as well as class 1,000 and the ultra-clean class 100 air quality areas (the class specifies the number of particles per 1,000 liters of air). This allows production and handling of nanomedicines with minimal risk of entraining foreign particles. All of the R&D labs employ deionized water. For critical processes, WFI-quality water is also produced on site in quantities needed to support the production scale (WFI = water for injection, comprises a specification of water quality that specifies minimal endotoxins and maximum sterility).
http://www.prnewswire.com/news-releases/nanoviricides-inc-completes-purchase-of-cgmp-compliant-pilot-production-facility-300017051.html
NanoViricides : Reports that the FluCideR Candidate was found to be Very Safe in cGLP-like Safety and Toxicology Study in Rats Performed by BASi
WEST HAVEN, Conn., Jan. 23, 2015 /PRNewswire/ -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company"), a nanomedicine company developing anti-viral drugs, reported a good safety profile of an optimized FluCideR drug candidate in a GLP-like toxicology study in rats. These results are extremely important since they indicate that FluCide continues to look very promising as one of the most advanced candidates in the Company's drug development pipeline.
...
No direct adverse clinical effects were found upon administration of the FluCide candidate intravenously at doses of up to 300mg/kg/day for 14 days (a total of 4,200mg/kg) in rats. Organs were examined for gross histological observations. Microscopic histological tissue analysis was also performed.
There were no adverse histological findings in gross organ level histological examination, nor were there any adverse findings in microscopic histological analysis. Equally importantly, there were no meaningful effects observed on animal weight gain, food consumption, hematology, or clinical chemistry at the end of the 14 day dosing period.
The study was conducted at BASi (Bioanalytical Systems, Inc., NASDAQ: BASI) in Evansville, Indiana. The study was performed in a cGLP-like fashion, compliant with BASi Evansville standard operating procedures. BASi has over 40 years of experience providing contract research services and niche instrumentation to the life sciences, primarily drug research and development.
These results are in agreement with the previously reported results of a non-GLP toxicology study in mice. The current study results also support the Company's positive findings in animal models of infection with different influenza A virus strains in which no safety or toxicology concerns were observed. The Company has previously reported that many of its FluCide candidates demonstrated extremely high anti-influenza activity in those models.
This study was developed in collaboration with BASi and conducted by BASi in a cGLP-like fashion in order to understand the safety parameters of FluCide intravenous dosing.
The next phase of the toxicology package studies will involve larger animals, and will require much larger quantities of the drug candidate. The Company is in the process of commissioning operations at the new 1 Controls Drive, Shelton, CT facility in order to perform the scale up studies needed for making the large quantities of materials in a controlled manner. These upcoming studies will be performed in cGLP compliant manner to provide safety and toxicology data that are required for an IND submission to regulatory agencies.
http://www.4-traders.com/NANOVIRICIDES-INC-15311537/news/NanoViricides--Reports-that-the-FluCide-Candidate-was-found-to-be-Very-Safe-in-cGLP-like-Safety-an-19751467/
"We wanted to take a very complex process, chemical synthesis, and make it simple," explained Burke. "Simplicity enables automation, which, in turn, can broadly enable discovery and bring the substantial power of making molecules to nonspecialists."
"The vision for the future is that anyone who needs a specific small molecule can essentially print it out from their computer," explained Burke. "We are really excited about the immediate impacts that this will have on drug discovery."
"by the way, I'm sure that when you think human trials for drugs you think of hundreds of millions of dollars and years of time, well in this case because the disease only lasts a week, two weeks,...that it is possible to complete human trials in the space of a few short months...four parts to the human trials" ~ Dr. Eugene Seymour, Nanoviricides, Inc.
"It is not easy to convey, unless one has experienced it, the dramatic feeling of sudden enlightenment that floods the mind when the right idea finally clicks into place. One immediately sees how many previously puzzling facts are neatly explained by the new hypothesis. One could kick oneself for not having the idea earlier, it now seems so obvious. Yet before, everything was in a fog."
NanoViricides, Inc. Signs CRADA for Material Transfer with USAMRIID for Evaluating Its Anti-Ebola Drug Candidates
WEST HAVEN, CONNECTICUT -- Monday, October 27, 2014 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a nanomedicine company developing anti-viral drugs, announced today that it has executed a CRADA (Collaborative Research and Development Agreement for Material Transfer) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). Certain novel anti-Ebola nanomedicine drug candidates recently developed by the Company will be evaluated by USAMRIID scientists in their BSL-4 facilities for activity against the deadly Ebola virus under this agreement.
"We are very happy to restart our collaboration with USAMRIID for developing an effective drug against the deadly Ebola virus," said Dr. Eugene Seymour, MD, MPH, CEO of NanoViricides, Inc., adding, "We intend to ship the samples as soon as the synthesis of the new drug candidates is completed."
The current Ebola epidemic that began in West Africa around December 2013-February 2014, has started producing sporadic cases elsewhere in the world. All of these cases have originated with people that have been to the epidemic-affected regions. However, local transmission has occurred in health care workers in the USA as well as in Spain. This epidemic continues to expand both geographically and numerically, exponentially, and containment efforts have had a very limited impact to date. More than 4,500 deaths have been reported, with a case fatality rate estimated at about 70%. As important as control measures are to limit the disease spread, a therapeutic drug is absolutely needed to effectively contain such a rapidly spreading epidemic.
There are currently no effective drugs or vaccines available for combating Ebola virus infection. The few cases of successful treatment with potential drug candidates had also received serum from survivors.
NanoViricides undertook the extreme challenge of developing a drug to combat this disease in a "war-like" timeline. We believe that we can develop an effective drug rapidly compared to other approaches, because of the inherent strength of our nanoviricides® platform technology.
The Company has recently developed and is now synthesizing test quantities of its novel nanoviricide drug candidates against Ebola that it believes could lead to a successful therapeutic. These drug candidates are designed to mimic the host cell receptor onto which the Ebola virus binds to cause an infection. The site at which the virus binds does not change, in spite of mutations. Thus the Company believes that its drug candidates would continue to work in spite of field mutations in the virus. This is unlike vaccines, antibodies, siRNA, antisense, and several other therapeutic modes, which a virus can readily overcome due to mutations it acquires in the field.
"We are using scalable processes so that we can rapidly transfer synthesis to kg-scale production, which we believe will be sufficient to contain the spread of the current Ebola epidemic," said Anil R. Diwan, PhD, President and Chairman of the Company, adding, "We believe that the collaboration with USAMRIID will enable timely testing of our candidates in an effort to rapidly zero in on a final drug candidate against Ebola."
EbolaCide2 - Plan of attack
Re: USAMRIID
Corinne (Scully) is gone and Gene (Olinger) is at the NIH virology labs
I'm in touch with Gene and would love to work with him.
We're shooting for a mid-November ship date but that's completely dependent on completing the synthesis of all the variants. Usually we make 8 variants, send them for testing, take the best two, expand them and make another eight.
This time, we're making many more and they'll all be tested during the same pass to save time.
If this works as we hope, I want to get EbolaCide to Africa ASAP!
EUGENE SEYMOUR - Chief Executive Officer & Director
October 31, 2014
It has been 35 days from 60---any updates from your government?
Countdown to catastrophe: UN warns world has just 60 DAYS to stop Ebola outbreak
Oct 15, 2014 12:19
By Sam Adams
The organisation says the virus is 'running faster than us and it is winning the race' as it continues to ravage West Africa and spread across the globe
"Face, nose, mouth, everything."
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MailOnline further reported:
On Tuesday evening, a Hazmat team was back on the scene to run tests, setting up across the street from the hair salon.
It was not clear why Amy Professional Hair Braiding would not have been evacuated until it was certain the woman did not have Ebola.
The salon was decontaminated late on Tuesday by a Hazmat crew.
According to a source who was on the scene, the incident occurred just after 3pm on Tuesday.
Emergency medical response personnel pronounced the woman dead at the scene.
"We were in the building and all the sudden the other owner came from the store and he said somebody dropped dead in their store," said a man named Costa, who works next door to the salon. He added that he ran into the salon and found the woman lying on the floor.
When asked by reporters where she was bleeding, he answered: "Face, nose, mouth, everything."
'Non-Ebola incident'?
FDNY personnel in hazmat gear said they donned protective equipment before going into the store in response to a "fever travel illness." The emergency medical personnel also said that they found a "clean scene" -- no body fluids leaving the woman's body at all, which of course does not square with eyewitness accounts.
In October, the FDNY issued a memo instructing all personnel to refer to Ebola in more vague terms, such as "fever travel incident."
New York City health authorities were on the scene to take blood samples from the woman, the MailOnline report said. Those personnel, along with emergency responders, were all run through decontamination processes.
In a statement to ABC News, an unnamed NYC health official said:
Earlier today, an individual who came to the U.S. from one of the three Ebola-impacted nations in West Africa within last three weeks died of an apparent non-Ebola condition. This individual at no time showed any symptoms of Ebola. However, due to travel history and an abundance of caution, an Ebola test will be performed on this individual's remains. Test results are expected later tonight or early tomorrow morning...
Ebola Spreading Intensely In Sierra Leone As Death Toll Rises: WHO
By Stephanie Nebehay
GENEVA, Nov 19 (Reuters) - The toll in the Ebola epidemic has risen to 5,420 deaths out of 15,145 cases in eight countries, the World Health Organization (WHO) said on Wednesday, with transmission of the deadly virus still "intense and widespread" in Sierra Leone.
The figures, through Nov. 16, represent a jump of 243 deaths and 732 cases since those issued last Friday, and cases continue to be under-reported, the WHO said in its latest update.
Sierra Leone, a former British colony, confirmed 533 new cases in the week to Nov. 16, it said, accounting for much of the increase. It also reported 63 deaths since last Friday.
"Much of this was driven by intense transmission in the country's west and north," the WHO said.
The capital Freetown, which accounted for 168 new confirmed cases, and nearby Port Loko were particularly hard-hit.
A Cuban doctor infected with Ebola in Sierra Leone will be flown to Switzerland in the next 48 hours for hospitalization in Geneva, Swiss health authorities said on Wednesday. He is the first Cuban known to have contracted the disease.
The outbreaks in Guinea and Liberia currently appear to be driven by intense transmission in several key districts, the WHO said, citing N'Zerekore and Macenta in Guinea and Montserrado in Liberia, which includes the capital Monrovia.
In the three most affected countries - Guinea, Liberia and Sierra Leone - 1,159 beds are now operational in 18 Ebola treatment centers, or one-quarter percent of beds planned, according to the U.N. agency. But only 13 percent of Ebola patients in Sierra Leone are in isolation, its figures show.
"As this number increases, so does the capacity to isolate patients and prevent further transmission of the disease."
Ebola Mutation: Lack Of Virus Samples In US Hampers Efforts To Track Its Changes
Samples of Ebola are in short supply for U.S. scientists who require a fresh, steady stock of the virus to track its changes and to plan ahead for new drugs and vaccines. Similar to the flu virus, Ebola mutates, however slightly, as it spreads, and keeping up with those changes is key to stopping new infections and heading off future outbreaks, according to Reuters.
"No one really knows right now what has the virus mutated to or if it has mutated," Charles Chiu, a microbiologist and infectious disease expert at the University of California, San Francisco, told Reuters. “We're not going to be able to determine in advance whether or not it has changed to a form where it might evade diagnostic assays or might render current vaccines or drugs ineffective” without new samples of the virus, he said.
Moving Ebola samples safely from one place to another is complicated, and transport companies have been wary of working with Ebola because of growing concerns about a U.S. spread of the virus. Doctors in Guinea, Liberia and Sierra Leone, where infections have topped 13,500 people, have been slow to hand over samples of Ebola, scientists told Reuters, which means U.S. disease specialists studying the virus at eight major research institutions are not getting the latest specimens.
As Ebola continues to spread across West Africa, it has more chances to change and adapt. Scientists identified 341 mutations of the virus as of late August, according to a study published that month in Science. One fear is that the virus could become more transmissible by becoming less pathogenic. A virus that sickens and kills its victims more slowly would leave more time for patients to infect others, National Geographic reported. The biggest nightmare, scientists have said, would be if the virus went airborne, something experts believe is highly unlikely but not impossible.
Obama Indemnifies Gov’t Contractors From Damages Arising from Importing Ebola to US
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An unnamed spokesperson for the agency responded: “Yes. The indemnification applies only to the extent that the claim, loss, or damage arises out of or results from exposure to Ebola in the course of performance of a contract and exceeds applicable insurance coverage.”
In other words, if a Company A employee contracts Ebola while working in West Africa, brings the disease back to the United States, is not quarantined and ends up infecting members of the general public, Company A is protected from any damages arising from lawsuits by these secondary victims.
According to the USAID spokesperson, employees of these contracted companies "provide essential services, including medical and non-medical management of Ebola patients."
In his memorandum, Obama justified his actions by citing Public Law 85-804, which allows the president to give any federal agency or department connected to national security the authority to enter into, amend or modify contracts with private companies in order to “facilitate the national defense.”
How does a doctor/surgeon native of Sierra Leone, a doctor that happens to be a legal resident of the U.S., goes 13 to 14 days with Ebola, treatment delays and not until the 13th day receives Zmapp and a plasma transfusion from an Ebola survivor???
Doctor with Ebola dies at Nebraska hospital
Washington (AFP) - A surgeon who was infected with Ebola while working in his native Sierra Leone died Monday, becoming the second patient in the United States to succumb to the hemorrhagic virus.
Martin Salia, 44, a legal US resident, was infected with Ebola while treating patients in his home country. The virus has killed thousands in West Africa since the start of the year.
Salia was flown to Nebraska for treatment on Saturday, but doctors said he was unresponsive by the time he arrived, struggling to breathe and his organs were failing.
"Dr Salia was suffering from advanced symptoms of Ebola when he arrived at the hospital Saturday, which included kidney and respiratory failure," the Nebraska Medical Center said in a statement.
"He was placed on dialysis, a ventilator and multiple medications to support his organ systems in an effort to help his body fight the disease."
Salia, who had been ill with Ebola for 13 days by Saturday, was also given donated plasma from a survivor of Ebola and the experimental drug treatment ZMapp.
Twelve hours after arriving in Nebraska, he went into complete respiratory failure and his blood pressure dropped. He died around 4:00 am (1000 GMT) on Monday, his medical team said.
EBOLA VIRUS DISEASE PROGRESSION
Typically, Ebola virus infection runs its course within 14 to 21 days. Infection initially presents with nonspecific flu-like symptoms such as fever, myalgia, and malaise. As the infection progresses, patients exhibit severe bleeding and coagulation abnormalities, including gastrointestinal bleeding, rash, and a range of hematological irregularities, such as lymphopenia and neutrophilia. Cytokines are released when reticuloendothelial cells encounter virus, which can contribute to exaggerated inflammatory responses that are not protective. Damage to the liver, combined with massive viremia, leads to disseminated intravascular coagulopathy. The virus eventually infects microvascular endothelial cells and compromises vascular integrity. The terminal stages of Ebola virus infection usually include diffuse bleeding, and hypotensive shock accounts for many Ebola virus fatalities (for reviews, see references 9 and 28)
Obama Indemnifies Gov't Contractors From Damages Arising from Importing Ebola to US
November 14, 2014 - 10:09 AM
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In other words, if a Company A employee contracts Ebola while working in West Africa, brings the disease back to the United States, is not quarantined and ends up infecting members of the general public, Company A is protected from any damages arising from lawsuits by these secondary victims.
According to the USAID spokesperson, employees of these contracted companies "provide essential services, including medical and non-medical management of Ebola patients."
In his memorandum, Obama justified his actions by citing Public Law 85-804, which allows the president to give any federal agency or department connected to national security the authority to enter into, amend or modify contracts with private companies in order to “facilitate the national defense.”
Fearful Mali places almost 600 under Ebola surveillance
US authorities on Monday began enhanced Ebola screenings of travellers from Mali, adding it to a list of three other west African countries -- Liberia, Sierra Leone and Guinea -- where the measures were already in place.
The US Centers for Disease Control and Prevention, in a joint statement with the Department of Homeland Security, said Mali was added to the list "because there have been a number of confirmed cases of Ebola" there in recent days.
AP IMPACT: If Ebola batters US, we are not ready
The U.S. health care apparatus is so unprepared and short on resources to deal with the deadly Ebola virus that even small clusters of cases could overwhelm parts of the system, according to an Associated Press review of readiness at hospitals and other components of the emergency medical network.
Ebola In US Cured, Craig Spencer Released From Hospital, America All Clear [Video]
Bill for Ebola Adds Up as Care Costs $1,000 an Hour
The care provided Ebola patient Thomas Eric Duncan may have cost as much as half a million dollars, a bill Texas Health Presbyterian Hospital Dallas is unlikely to ever collect.
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Duncan had been in isolation in the hospital for nine days. "If they recognize that he has no money they will clearly just write it off as charity care," Anderson said in a telephone interview yesterday before Duncan's death was announced.
Schumer to Obama: Reimburse NYC for $20M Ebola treatment
Senator Charles Schumer wants President Obama to pick up New York City’s more than $20 million tab for treating its first Ebola patient.
Exclusive: MSF should have called for Ebola vaccine earlier, says aid group veteran
(Reuters) - Medecins Sans Frontiers "wasted time" by waiting too long to call for vaccines to fight an unprecedented outbreak of Ebola in West Africa, a veteran of the medical charity told Reuters.
The group's response to the epidemic which has so far killed more than 5,000 people has been widely praised by governments and the World Health Organization. While Western donors dithered and other aid groups pulled out, MSF deployed hundreds to the Ebola "hot zones" and treated more than 3,000 patients.
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"We wasted time before speaking about a vaccine and treatments... It's very hard to imagine controlling this epidemic now without a vaccine."
(Reuters) - Scientists across the United States say they cannot obtain samples of Ebola, complicating efforts to understand how the virus is mutating and develop new drugs, vaccines and diagnostics.
The problems reflect growing caution by regulators and transport companies about handling Ebola as well as the limited resources of West African countries which are struggling to help thousands of infected citizens.
Ten scientists from eight major research institutions contacted by Reuters reported they were unable to get Ebola samples in recent months.
According to Charles Chiu, a microbiologist and infectious disease expert at the University of California, San Francisco, the best experts in the field don't even know if Ebola has mutated beyond recognition because tracking has deteriorated. As it currently stands, samples of the virus are nowhere to be found, which poses a major public health threat.
"No one really knows right now what has the virus mutated to or if it has mutated," stated Chiu to Reuters. "We're not going to be able to determine in advance whether or not [Ebola] has changed to a form where it might evade diagnostic assays or might render current vaccines or drugs ineffective."
Ebola In US Cured, Craig Spencer Released From Hospital, America All Clear [Video]
A cure for human Ebola infection? Not just yet.
What does this recent advance mean? Can we expect a post-exposure treatment for humans? Or better yet, a vaccine? Scientists caution this is certainly a big step forward, but many challenges remain before the treatment can be applied to an outbreak in humans. For example, the amount of antibodies needed to treat a larger group of people would be difficult to manufacture.
...
For a first-person account of the initial detection of the Ebola virus, listen to this interview from NPR's Talk of the Nation with Peter Piot, a member of the 1976 team who first identified Ebola, as he discusses his memories of the discovery and his long career in virology.
Obama Indemnifies Gov't Contractors From Damages Arising from Importing Ebola to US
November 14, 2014 - 10:09 AM
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In other words, if a Company A employee contracts Ebola while working in West Africa, brings the disease back to the United States, is not quarantined and ends up infecting members of the general public, Company A is protected from any damages arising from lawsuits by these secondary victims.
According to the USAID spokesperson, employees of these contracted companies "provide essential services, including medical and non-medical management of Ebola patients."
In his memorandum, Obama justified his actions by citing Public Law 85-804, which allows the president to give any federal agency or department connected to national security the authority to enter into, amend or modify contracts with private companies in order to “facilitate the national defense.”
Antigua and Barbuda, Belize, Canada - The authorities on 31 October suspended the issuance of visas to travellers who have recently visited West African countries affected by the Ebola virus. The action covers those who have travelled to Guinea, Liberia and Sierra Leone in the past three months, Colombia imposed an entry ban from 14 October on any traveller who has visited Guinea, Liberia, Nigeria, Senegal or Sierra Leone in the past four weeks. The restriction would also reportedly apply to Colombian nationals. The Dominican Republic has banned entry to travellers who have been in the following countries in the past 30 days: Sierra Leone, Senegal, Liberia, Guinea, and Nigeria, as well as any countries that the World Health Organization has deemed to be affected by the Ebola virus. Guyana announced on 16 October that visas will not be issued to nationals from Guinea, Liberia, Sierra Leone and Nigeria. Furthermore, health officials will screen travellers who have visited these countries in the six weeks prior to their arrival in Guyana. Haiti has banned (PDF) entry to travellers who have been to Guinea, Liberia or Sierra Leone in the past 28 days. Travellers who have been to these countries more than 28 days before travel to Haiti must present a government-certified health certificate and the results of a blood test for the Ebola virus upon arrival. It is uncertain at this time how these measures will be carried out or enforced. International SOS is monitoring the situation. Jamaica imposed an entry ban from 16 October for travellers arriving from Guinea, Liberia and Sierra Leone, as well as those who have visited these countries within the four weeks prior to their arrival. In addition, any Jamaican national who travels to the aforementioned countries will be quarantined for 28 days on return. Panama on 22 October banned the entry of travellers who have visited Guinea, Liberia and Sierra Leone in the past 21 days. The ban will remain in place until the three countries are declared Ebola-free. St Kitts and Nevis have restricted the entry of nationals from Guinea, Liberia and Sierra Leone. Similar measures will also be applied to travellers who have visited these countries in the 21 days prior to arrival. St Lucia has banned visitors from Guinea, Liberia and Sierra Leone. The government has also announced that, in addition to a visa, visitors from Nigeria will be required to present a recent medical certificate clearing them of the virus. No further details are available at this stage, though we are investigating further. St Marteen has said that visitors who have travelled to, from or through Democratic Republic of Congo, Guinea, Liberia and Sierra Leone in the past 21 days will be denied to enter or transit the country. Individuals returning from the above countries who live in St Maarten will be allowed to enter on condition that they agree to be quarantined for at least 21 days upon arrival. St Vincent and the Grenadines has banned visitors from Guinea, Nigeria and Sierra Leone. Suriname has banned entry to foreign travellers who have been to Guinea, Liberia and Sierra Leone in the past 21 days, unless they can present an ‘internationally recognised health certificate’ clearing them of the virus. No further details are available at this time. Trinidad and Tobago announced on 16 October that it would deny entry to nationals of Congo (DRC), Guinea, Liberia, Nigeria and Sierra Leone. In addition, travellers who have visited any of the aforementioned countries in the past six weeks will be quarantined for 21 days upon arrival. The United States announced that beginning 22 October, any passengers beginning their travels in Liberia, Sierra Leone or Guinea will only be able to enter the country through the following airports: JFK International Airport (JFK, New York state), Newark International Airport (EWR, New Jersey), Dulles International Airport (IAD, Washington, DC), Hartsfield-Jackson International Airport (ATL, Georgia) or Chicago O'Hare International Airport (ORD, Illinois).
Others
Australia has suspended the issuance of visas to travellers from Guinea, Liberia and Sierra Leone. Travellers from these countries who hold permanent visas can enter Australia if they have been quarantined for 21 days prior to arrival, while those who have received non-permanent visas and who have not departed for Australia will have their visas cancelled.
North Korea has banned foreign tourists since 24 October over fears of ebola; the ban applies to all entry points and border crossings. All other visitors will reportedly be required to spent 21 days in government-supervised quarantine, regardless of their country of origin or point of departure.
Singapore: The authorities have announced that 5 November onwards nationals of Guinea, Liberia and Sierra Leone will require visas to enter the country. The government also said that nationals of the three countries, as well as citizens of Congo (DRC) and Mali, will be screened for fever at all entry points. Other travellers who have visited these countries recently will also be screened.
House Speaker John Boehner on Wednesday urged President Barack Obama to consider a temporary ban after two American nurses contracted the virus from a Liberian man who flew to Dallas to visit family, according to CBS News
AP IMPACT: If Ebola batters US, we are not ready
The U.S. health care apparatus is so unprepared and short on resources to deal with the deadly Ebola virus that even small clusters of cases could overwhelm parts of the system, according to an Associated Press review of readiness at hospitals and other components of the emergency medical network.
Bill for Ebola Adds Up as Care Costs $1,000 an Hour
The care provided Ebola patient Thomas Eric Duncan may have cost as much as half a million dollars, a bill Texas Health Presbyterian Hospital Dallas is unlikely to ever collect.
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Duncan had been in isolation in the hospital for nine days. "If they recognize that he has no money they will clearly just write it off as charity care," Anderson said in a telephone interview yesterday before Duncan's death was announced.
Schumer to Obama: Reimburse NYC for $20M Ebola treatment
Senator Charles Schumer wants President Obama to pick up New York City’s more than $20 million tab for treating its first Ebola patient.
Exclusive: MSF should have called for Ebola vaccine earlier, says aid group veteran
(Reuters) - Medecins Sans Frontiers "wasted time" by waiting too long to call for vaccines to fight an unprecedented outbreak of Ebola in West Africa, a veteran of the medical charity told Reuters.
The group's response to the epidemic which has so far killed more than 5,000 people has been widely praised by governments and the World Health Organization. While Western donors dithered and other aid groups pulled out, MSF deployed hundreds to the Ebola "hot zones" and treated more than 3,000 patients.
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"We wasted time before speaking about a vaccine and treatments... It's very hard to imagine controlling this epidemic now without a vaccine."
(Reuters) - Scientists across the United States say they cannot obtain samples of Ebola, complicating efforts to understand how the virus is mutating and develop new drugs, vaccines and diagnostics.
The problems reflect growing caution by regulators and transport companies about handling Ebola as well as the limited resources of West African countries which are struggling to help thousands of infected citizens.
Ten scientists from eight major research institutions contacted by Reuters reported they were unable to get Ebola samples in recent months.
According to Charles Chiu, a microbiologist and infectious disease expert at the University of California, San Francisco, the best experts in the field don't even know if Ebola has mutated beyond recognition because tracking has deteriorated. As it currently stands, samples of the virus are nowhere to be found, which poses a major public health threat.
"No one really knows right now what has the virus mutated to or if it has mutated," stated Chiu to Reuters. "We're not going to be able to determine in advance whether or not [Ebola] has changed to a form where it might evade diagnostic assays or might render current vaccines or drugs ineffective."
Ebola In US Cured, Craig Spencer Released From Hospital, America All Clear [Video]
A cure for human Ebola infection? Not just yet.
What does this recent advance mean? Can we expect a post-exposure treatment for humans? Or better yet, a vaccine? Scientists caution this is certainly a big step forward, but many challenges remain before the treatment can be applied to an outbreak in humans. For example, the amount of antibodies needed to treat a larger group of people would be difficult to manufacture.
.
For a first-person account of the initial detection of the Ebola virus, listen to this interview from NPR's Talk of the Nation with Peter Piot, a member of the 1976 team who first identified Ebola, as he discusses his memories of the discovery and his long career in virology.
Obama Indemnifies Gov't Contractors From Damages Arising from Importing Ebola to US
November 14, 2014 - 10:09 AM
.
.
.
In other words, if a Company A employee contracts Ebola while working in West Africa, brings the disease back to the United States, is not quarantined and ends up infecting members of the general public, Company A is protected from any damages arising from lawsuits by these secondary victims.
According to the USAID spokesperson, employees of these contracted companies "provide essential services, including medical and non-medical management of Ebola patients."
In his memorandum, Obama justified his actions by citing Public Law 85-804, which allows the president to give any federal agency or department connected to national security the authority to enter into, amend or modify contracts with private companies in order to “facilitate the national defense.”
African nations including Kenya, Zambia, and South Africa make up the bulk of the countries that have instituted some kind of ban, and now that countries on the other side of the Atlantic have begun imposing restrictions, calls for the United States to follow suit have intensified.
Here is the complete list of nations with bans or significant travel restrictions:??
Angola?
Botswana?
Cameroon?
Chad?
Colombia (South America)
Congo (DRC)?
Equatorial Guinea?
Gabon?
Gambia?
Ivory Coast
Kenya?
Lesotho?
Madagascar?
Malawi?
Mauritius?
Morocco
Mozambique?
Namibia?
Nigeria?
Rwanda?
St. Lucia
Senegal?
South Africa?
South Sudan?
Swaziland?
Tanzania?
Togo?
Zambia ?
Zimbabwe?
House Speaker John Boehner on Wednesday urged President Barack Obama to consider a temporary ban after two American nurses contracted the virus from a Liberian man who flew to Dallas to visit family, according to CBS News.
AP IMPACT: If Ebola batters US, we are not ready
The U.S. health care apparatus is so unprepared and short on resources to deal with the deadly Ebola virus that even small clusters of cases could overwhelm parts of the system, according to an Associated Press review of readiness at hospitals and other components of the emergency medical network.
Bill for Ebola Adds Up as Care Costs $1,000 an Hour
The care provided Ebola patient Thomas Eric Duncan may have cost as much as half a million dollars, a bill Texas Health Presbyterian Hospital Dallas is unlikely to ever collect.
.
.
.
Duncan had been in isolation in the hospital for nine days. "If they recognize that he has no money they will clearly just write it off as charity care," Anderson said in a telephone interview yesterday before Duncan's death was announced.
WASHINGTON (Reuters) - A surgeon infected with Ebola in Sierra Leone will be flown to the University of Nebraska Medical Center for treatment, "CBS Evening News" reported on Thursday.
The surgeon was born in Sierra Leone but is a U.S. resident, CBS reported.
University of Nebraska Medical Center officials declined to confirm the report but said in a statement that a patient who contracted the disease in Sierra Leone was being evaluated for possible treatment at the hospital.
"He will be evaluated by the medical crew on the Phoenix Air jet upon their arrival in Sierra Leone," the hospital said. "The members of the crew will determine whether the patient is stable enough for transport - if he is, he would arrive in Omaha sometime Saturday afternoon."
What are Intramuscular Injections?
An intramuscular injection is a technique used to deliver a medication deep into the muscles. This allows the medication to be absorbed into the bloodstream quickly. You may have received an intramuscular injection at a doctor’s office the last time you got a vaccine, like the flu shot.
What are Intramuscular Injections Used For?
Intramuscular injections are used to deliver drugs and vaccines. They are a common practice in modern medicine. Several drugs and almost all inactivated vaccines are delivered this way.
Intramuscular injections are used when other types of delivery methods are not recommended. These include oral (swallowed into the stomach), intravenous (injected into the vein), and subcutaneous (injected just under the layer of skin).
The speed of absorption is faster for intramuscular injection compared to subcutaneous injection. This is because the muscle tissue has a greater blood supply than the area just under the skin. Muscle tissue may also hold a larger volume of medication than subcutaneous tissue.
Intramuscular injection may be used instead of intravenous injection because some drugs are irritating to veins. Sometimes, a suitable vein cannot be located. It may be used instead of oral delivery because some drugs are destroyed by the digestive system when a drug is swallowed
"We believe the new anti-Ebola ligands should make the new drug candidates substantially superior to our older ones, based on the molecular modeling studies we have conducted using the structural information of interaction of Ebola virus glycoprotein with its cellular receptor Niemann-Pick C1 protein," said Anil R. Diwan, PhD, President of the Company, "We believe that Ebola virus will not be able to avoid our drug candidates in spite of mutations, because we are mimicking NPC1, the receptor to which the virus must bind in order to infect the host cell. Of course, we must await results from actual cell culture and animal testing to further develop these candidates."
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NanoViricides, Inc. now has the capability of producing sufficient quantities of an anti-Ebola drug, after it is developed, for combating current and future Ebola epidemics. The highly customizable nanomedicine cGMP capable pilot scale manufacturing facility in Shelton, CT, will be able to supply all of the nanoviricides drug candidates in quantities needed for human clinical trials.
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As of September 5, 2014, the World Health Organization (WHO) and the Centers for Disease Control (CDC) reported a total of 3,967 suspected cases and 2,105 deaths, according to Wikipedia (en.wikipedia.org/wiki/Ebola_virus_epidemic_in_West_Africa). WHO has reported an overall case fatality rate estimate of 52%, considerably lower than that reported from previous outbreaks. Unfortunately, this Ebola outbreak has continued to expand at an exponential rate in spite of significant efforts to contain it.
Currently, there are no approved drugs or vaccines against Ebola, although some vaccines as well as some drug candidates have entered clinical trials. Recently, WHO has announced a policy for use of experimental drugs against Ebola to expedite drug availability.
Why the Ebola virus is so deadly
It is not the virus that directly causes the infamous bleeding. Yes, the virus attacks different organs as well as the immune system, but the most serious problem is a severe over-reaction by our own immune system, called a cytokine storm. This causes blood clotting in all the wrong places, called disseminated intravascular coagulation,24 which damages organs such as the liver. Also, this uses up all the blood clotting factors, meaning that clots won’t form where they should, resulting in uncontrollable bleeding.25,26 It’s notable that the deadliest epidemic of Ebola’s fellow negative-sense–RNA virus influenza also caused cytokine storms. This is why the pandemic killed so many previously healthy people—they had the strongest immune systems, and these were turned against them. In the case of influenza, the immune system severely inflamed the patient’s lungs.27
At present there is no cure or vaccine for Ebola. Treatment involves rehydration, pain relief, and pro-coagulants to control bleeding. Also, there is blood transfusion to replace loss, as well as blood plasma from Ebola survivors containing antibodies that could fight the disease. Indeed, Dr Brantly was helped by a 14-year-old former patient’s transfusion, and he has since donated blood plasma to other sufferers.28
“This isn't about going back, it's about life being ahead of you and you run at it! Because you never know how far you can go unless you run.” ? Penny Chenery, owner of the "Flying Horse" Secretariat
It has been 30 days from 60---any updates from your government?
Countdown to catastrophe: UN warns world has just 60 DAYS to stop Ebola outbreak
The organisation says the virus is 'running faster than us and it is winning the race' as it continues to ravage West Africa and spread across the globe
(Reuters) - Scientists across the United States say they cannot obtain samples of Ebola, complicating efforts to understand how the virus is mutating and develop new drugs, vaccines and diagnostics.
The problems reflect growing caution by regulators and transport companies about handling Ebola as well as the limited resources of West African countries which are struggling to help thousands of infected citizens.
Ten scientists from eight major research institutions contacted by Reuters reported they were unable to get Ebola samples in recent months.
Ebola accelerates in Sierra Leone with 900% higher transmission rate
(NaturalNews) Things have been relatively quiet on the Ebola front here in the U.S. this past week, with 11 days and counting (as of this writing) since the last confirmed case of the disease was announced. But the situation is hardly as rosy in Sierra Leone, where an Africa Governance Initiative (AGI) report says Ebola is now spreading at a 900 percent faster rate than two months ago.
In early September, the official number was 1.3 new cases of Ebola per day in Sierra Leone, one of the three "ground zero" countries that has been most ravaged by the virus. Now, that number has escalated to 12 new cases per day in the rural areas surrounding Freetown, the country's capital, representing a more than nine-fold increase.
Number of Ebola-affected orphans in Liberia triples; patients mysteriously 'disappearing'; epidemic out of control in 80% of country
Thursday, November 13, 2014 by: J. D. Heyes
As MailOnline further reported:
This is the brutal truth about the outbreak that has ravaged West Africa and reached the U.S., Spain, Germany, and the U.K: not only are huge numbers of carriers simply 'disappearing' from official figures, but the number of children left orphaned is at least three times the size of existing estimates.
(NaturalNews) Defying its own quack advice that the agency has been propagandizing for months, the CDC has now released a document on Ebola that admits the virus can spread through aerosolized droplets. The document, quietly released on the CDC website, also admits Ebola can contaminate surfaces such as doorknobs, causing infections to be spread through indirect means. [1]
Here's a backup source of the PDF just in case the CDC scrubs it:
http://www.naturalnews.com/files/infections-spread-by-air-or-droplets.pdf
In other words, the CDC is now admitting it lied all along and that Natural News was correct from day one when we warned you about indirect transmission routes of the Ebola virus. (The CDC has always insisted it could only spread via "direct contact.")
"Ebola is spread through droplets," the CDC document now reads. Mirroring exactly what I've been telling millions of people in my free audio course at www.BioDefense.com the CDC now says "A person might also get infected by touching a surface or object that has germs on it and then touching their mouth or nose."
Yeah, we know. In fact, everybody in the independent media has known this for months, while all those who watch mainstream media sources are just now realizing this because they've been repeatedly lied to by CDC and NIH spokespeople.
The CDC has offered no apology whatsoever for intentionally misleading the public up to this point. Apparently, lying to the public is such a common activity at the highest levels of the CDC that they don't think there's anything wrong with it.
Ebola Virus Infection Treatment & Management
Author: John W King, MD; Chief Editor: Burke A Cunha, MD
Pharmacologic Therapy
Nucleoside analogue inhibitors of the cell-encoded enzyme S-adenosylhomocysteine hydrolase (SAH) have been shown to inhibit Zaire ebolavirus replication in adult BALB/c mice infected with mouse-adapted Ebola virus.[21] Inhibition of SAH indirectly inhibits transmethylation reactions required for viral replication. Treatment response was dose-dependent. When doses of 0.7 mg/kg or more every 8 hours were begun on day 0 or 1 of infection, mortality was completely prevented. Even when the drug was given on day 2, 90% survived.
Smith et al found that in rhesus macaques infected with a lethal dose of Ebola virus, treatment with interferon beta early after exposure led to a significant increase in survival time, though it did not reduce mortality significantly.[22] These findings suggest that early postexposure interferon-beta therapy may be a promising adjunct in the treatment of Ebola virus infection.
Passive immunity has been attempted by using equine-derived hyperimmune globulins and human-derived convalescent immune globulin preparations. In Ebolavirus -infected cynomolgus macaques, use of human recombinant interferon alfa-2b in conjunction with hyperimmune equine immunoglobulin G (IgG) delayed but did not prevent death.
Equine IgG containing high-titer neutralizing antibodies to Ebola virus protected guinea pigs and baboons but was not effective in protecting infected rhesus monkeys.
During the 1995 outbreak in Kikwit, DRC, human convalescent plasma was used to treat 8 patients with proven Ebola disease, and only 1 patient died. Subsequent studies could not demonstrate survival benefit conferred by convalescent plasma products. The survival of these patients suggests that passive immunity may be of benefit in some patients.
Four laboratory workers in Russia who had possible Ebola exposure were treated with a combination of a goat-derived anti-Ebola immunoglobulin plus recombinant human interferon alfa-2. One of these patients had a high-risk exposure and developed clinical evidence of Ebola virus infection. All 4 patients recovered.
A recombinant human monoclonal antibody directed against the envelope glycoprotein (GP) of Ebola virus has been demonstrated to possess neutralizing activity. This Ebola virus-neutralizing antibody may be useful in vaccine development or as a passive prophylactic agent.
DNA vaccines expressing either envelope GP or nucleocapsid protein (NP) genes of Ebola virus have been demonstrated to induce protection in adult mice exposed to the virus. These vaccines were administered by coating gold beads with DNA expressing the genes for either GP or NP, and they were delivered by skin particle bombardment using a PowderJect-XR gene gun. Both vaccines induced measurable antibody responses detected by enzyme-linked immunosorbent assay (ELISA) and induced cytotoxic T-cell immunity.
Other experimental therapies that use available drugs, though not approved by the US Food and Drug Administration (FDA) for treatment of Ebola virus infection, may be considered. Agents that may reduce mortality without directly effecting viral replication include activated protein C[2] and a recombinant nematode anticoagulant protein (NAP) that inhibits activated factor VII-tissue factor complex.[3] NAP resulted in attenuation of the coagulopathy associated with decreased fibrinolysis and fibrin deposition with a resultant decrease in the severity of the systemic inflammatory response syndrome.
In a rhesus macaque model of Ebola hemorrhagic fever, which carries a mortality approaching 100%, Geisbert et al administered recombinant nematode anticoagulant protein, a potent inhibitor of TF-initiated coagulation.[3] One third of the monkeys given the nematode anticoagulant protein survived a lethal dose of Ebola virus, whereas 16 of the 17 (94%) control animals died. This approach targeted the hemorrhagic disease component of the infection rather than the virus itself.
Doctor, Cured of Ebola, Released With Cheers, Hugs
Excellent post nanopatent. The plan, according to Dr. E. Seymour - CEO of NanoViricides, Inc., in a nutshell:
Proof of concept
First in humans
Validation of the rapid development program
Moves us from a pre-clinical to a clinical biopharma
World-wide recognition
NanoViricides, Inc. has rescued over 6,000 animals, infected with fatal doses of different viruses, from the jaws of death. We aim to perform the same kind of rescue on Ebola virus infected primates, at the USAMRIID, soon.
I'd like someone to point out a multi-million dollar investment from Dr. Milton Boniuk, one investment other than on the publicly traded company NanoViricides, Inc., one investment on which he and his chosen company have failed.